Received Jul 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | 52n4S | — |
introduced a syringe inside the prefilled syringe of Bexsero instead of following the instructions as per the PI; This non-serious case was reported by the other health professional via call center representative and described the occurrence of wrong technique in product usage process in a patient who received Men B NVS (Bexsero) (batch number 52n4S) for prophylaxis. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong technique in product usage process (Verbatim: introduced a syringe inside the prefilled syringe of Bexsero instead of following the instructions as per the PI). The outcome of the wrong technique in product usage process was not applicable. It was unknown if the reporter considered the wrong technique in product usage process to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the wrong technique in product usage process to be related to Bexsero and Bexsero 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: 18-JUL-2025 Healthcare professional reported that they introduced a syringe inside the prefilled syringe of Bexsero instead of following the instructions as per the prescribing information (PI) which led to wrong technique in product usage process.