Received Jun 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (HIBERIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 3A2KF | — |
Product splashed onto HCP; Product splashed onto HCP; leur lock adapters becoming loose and detaching and sometimes the leur lock adaptor spinned when the cap was removed; Pharmaceutical product complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of occupational exposure via skin contact with product in a 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 an unknown date, an unknown time after receiving Hiberix, the patient experienced occupational exposure via skin contact with product (Verbatim: Product splashed onto HCP), inadvertent exposure to vaccine (Verbatim: Product splashed onto HCP), syringe connection issue (Verbatim: leur lock adapters becoming loose and detaching and sometimes the leur lock adaptor spinned when the cap was removed) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the occupational exposure via skin contact with product, inadvertent exposure to vaccine, 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 Hiberix and Hiberix And Diluent Pre-Filled Syringe Device. It was unknown if the company considered the 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 luer lock adapter detached during injection and product splashed onto the HCP, which led to occupational exposure via skin contact with product and inadvertent exposure to vaccine. The reporter was unable to tell how much of the product was given and McKesson Thin Wall Needle 25g of 1 inch was used.; Sender's Comments: US-GSK-US2025023704:Same reporter different patient