Report #2879881

Overview

Sex

Unknown

Age

Age unknown

State

HI

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

medication squirted out the side instead of into the patient; Needle Unscrewing from Syringe while inside patientl; Pharmaceutical product complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number J4349, expiry date 17-JUN-2025) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received FluLaval 2024-2025 season. On an unknown date, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced accidental underdose (Verbatim: medication squirted out the side instead of into the patient), syringe connection issue (Verbatim: Needle Unscrewing from Syringe while inside patientl) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the accidental underdose, syringe connection issue and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the syringe connection issue to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device. It was unknown if the company considered the syringe connection issue to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 10-SEP-2024, 11-SEP-2024 and 12-SEP-2024 Healthcare provider left voicemail stating about defective FluLaval TIV syringes. The lot number was J4349. They have noticed the syringe was very bad at holding the needle securely. Just the pressure alone of pushing the vaccine out was enough to make the needle unscrew, and it had happened twice now inside of a patient. A few other people within company had reported this. No patients had been harmed. The needle of 25 gauge 5/8 inch was used. She said that it was the same brand of needle that she used for other GSK vaccines. She stated that she had used this same needle brand/size with other GSK Flulaval 2024-2025 season vaccines with a different lot number and did not had a problem with those. She thought that the problem was only with lot number J4349. She had lost confidence in that lot only because she had a problem of looseness with 3 boxes with lot J4349. She had unopen boxes of lot J4349 and she was reluctant to use them. She had one open box with lot number J4349 that has 4 unopen syringes. She will be sending those 4 unopen syringes back to GSK quality with an unopen needle. She was requesting a shipping box. The leur lock did not break off, the needle unscrewed off. When removing the cap, it screwed off. She said when she was screwing them on it felt unsecure. She said she could see how far to tighten it and she was not over-screwing them. She said that with two (pediatric) patients when injecting the needle did not stay all the way on and so some of the medication squirted out the side instead of into the patient (Adverse event related- Underdose). The doctor did not feel that either of these patients required a re-dose. Both of the patients were pediatric and sometimes pediatric patients can move around but both of these patients were calm during administration. She noticed that she could see the orange needle guard spinning as she was injecting the medicine which meant that the needle was unscrewing. Three boxes (26 syringes) with the lot number J4349 had the looseness. She stated that she can feel it when she attached the needle that it was loose and that even if she just bumps it with her thumb the needle will unscrew and come off. Those 26 syringes had been used and are in the sharps container. But she did take a video and will email that. She said that she got an email from the manager of two other clinics that also reported an issue with Flulaval syringes. She did not know how many syringes were affected by the other clinics and did not know the lot number of the syringes the other clinics were using. Follow-up information received on 11-OCT-2024 and 16-OCT-2024 Executive summary and conclusions of the QA statement was received as follows. GSK has completed its investigation for the quality defect that was reported. The investigation included a review of the defect trends, an examination of the complaint sample, a testing of the retained samples and a review of the related production records, all of which demonstrated that the reported batch was produced in compliance with the applicable procedures and met all required specifications. Nothing atypical was identified while the product was under GSK control which would explain the reported quality defect. The Safety Department within GSK routinely monitors safety signals (including signals potentially related to manufacturing); should a safety concern be detected, it will be managed and escalated according to processes in place. Given the outcome of its investigation, GSK considers the complaint that is the object of this report as unsubstantiated. The Safety Department within GSK routinely monitors safety signals (including signals potentially related to manufacturing); should a safety concern be detected, it will be managed and escalated according to processes in place. Summary of changes: Batch and lot tested and found not within specifications checkbox, expiry date and narrative updated. Follow up information received on 06-DEC-2024 GlaxoSmithKline had completed its investigation for the quality defect that was reported. The investigation included a review of the defect trends, an examination of the complaint sample, a testing of the retained samples and a review of the related production records, all of which demonstrated that the reported batch was produced in compliance with the applicable procedures and met all required specifications. Nothing atypical was identified while the product was under GlaxoSmithKline control which would explain the reported quality defect. The Safety Department within GlaxoSmithKline routinely monitors safety signals (including signals potentially related to manufacturing); should a safety concern be detected, it will be managed and escalated according to processes in place. Summary of changes: Narrative was updated. Upon internal review the case was updated on 11-FEB-2025 The suspect was updated from FluLaval Quadrivalent 2024-2025 season was updated to FluLaval 2024-2025 season. Summary of changes: Product details and narrative were updated. Follow up information received on 22-DEC-2025 GlaxoSmithKline had completed its investigation for the quality defect that was reported. The investigation included a review of the defect trends, an examination of the complaint sample (when available), a review of the retained samples and a review of the related production records, all of which demonstrated that the reported batch was produced in compliance with the applicable procedures and met all required specifications. The result of our investigation has identified contributive factors that may have led to this complaint. Consequently, to the identification of contributive factors of the reported issue, GlaxoSmithKline was taking any necessary actions to improve its processes to reduce the possibility of any future occurrence. The Safety Department within GlaxoSmithKline routinely monitors safety signals (including signals potentially related to manufacturing); should a safety concern be detected, it will be managed and escalated according to processes in place. GlaxoSmithKline apologizes for any inconvenience caused to the customer. According to the thorough investigation performed at the different production steps, contributive factors were identified at raw material level. Therefore, GSK considers the complaint that is the object of this report as substantiated. Summary of changes: The product, event and narrative updated.