Received Mar 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (HIBERIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 3A2KF | — |
leur lock adapters becoming loose and detaching Sometimes the leur lock adaptor spins when the cap is removed; Product complaint; Partially administered; the needle stayed in the patient; Product splashed onto patient; Product splashed onto patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental needle stick in a 12-month-old female patient who received Hib (Hiberix) (batch number 3A2KF, expiry date 14-JUL-2026) for prophylaxis. This case was associated with a product complaint. On 25-FEB-2025, the patient received Hiberix. On 25-FEB-2025, immediately after receiving Hiberix, the patient experienced accidental needle stick (Verbatim: the needle stayed in the patient), inadvertent exposure to vaccine (Verbatim: Product splashed onto patient), exposure via skin contact (Verbatim: Product splashed onto patient) and accidental underdose (Verbatim: Partially administered). On an unknown date, the patient experienced syringe connection issue (Verbatim: leur lock adapters becoming loose and detaching Sometimes the leur lock adaptor spins when the cap is removed) and pharmaceutical product complaint (Verbatim: Product complaint). The outcome of the accidental needle stick was unknown and the outcome of the inadvertent exposure to vaccine, exposure via skin contact, syringe connection issue, accidental underdose and pharmaceutical product complaint were not applicable. The reporter considered the accidental needle stick and syringe connection issue to be related to Hiberix and Hiberix And Diluent Pre-Filled Syringe Device. The company considered the accidental needle stick and syringe connection issue to be related to Hiberix and Hiberix And Diluent 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: 25-FEB-2025 The office manager reported the complaint of the rotating and detachment of the leur lock adapters and it was confirmed a leur lock needles were used and they had several issues with the leur lock adapters becoming loose and detaching and sometimes the leur lock adaptor spinned when the cap was removed, it spin when the needle was attached and also came completely off along with the needle during the injection. The reporter reported that during preparation for administration the defect was discovered for this current lot it was after partial use of the multipack and was partially administered, which led to accidental underdose. The luer lock adapter detached during injection and product splashed onto the HCP and the patient and the needle stayed in the patient, which led to inadvertent exposure to vaccine and exposure via skin contact. The reporter was unable to tell how much of the product was given and McKesson Thin Wall Needle 25g of 1 inch was used.