Received Feb 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (HIBERIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Defective vaccine potentially administered; getting leakage between the needle and the luer lock on the Prefilled Syringe; getting leakage between the needle and the luer lock on the Prefilled Syringe; Product Complaint; This non-serious case was reported by a other health professional via sales rep and described the occurrence of accidental underdose in a patient who received Hib (Hiberix) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced accidental underdose (Verbatim: Defective vaccine potentially administered), syringe leak (Verbatim: getting leakage between the needle and the luer lock on the Prefilled Syringe), syringe connection issue (Verbatim: getting leakage between the needle and the luer lock on the Prefilled Syringe) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the accidental underdose, syringe leak, syringe connection issue and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the syringe leak and syringe connection issue to be related to Hiberix and Hiberix And Diluent Pre-Filled Syringe Device. It was unknown if the company considered the syringe leak 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: 17-MAY-2024 GlaxoSmithKline Representative stated he was calling on behalf of an Office Administrator who reported a Product Quality Complaint this morning, mentioning that their clinic was having issues with Hiberix, when they put the needle onto the Prefilled Syringe and then try to draw they were getting leakage between the needle and the luer lock on the Prefilled Syringe. The Healthcare Provider mentioned it was 2 incidents out of this box, but understanding of the caller is that several kids were administered that morning which led to accidental underdose, syringe leak, syringe connection issue and pharmaceutical product complaint. Patient demographics, lot number or expiration date were unknown. Upon internal review case was updated on 14-FEB-2024 The suspect product was recoded.