Received May 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | M77CC | — |
medication leaked out of the prefilled syringe around the plastic; Product complaint; medication leaked onto my hand; medication leaked onto my hand; This non-serious case was reported by a other health professional and described the occurrence of occupational exposure via skin contact with product in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number M77CC) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Boostrix. On 07-MAY-2025, an unknown time after receiving Boostrix, the patient experienced occupational exposure via skin contact with product (Verbatim: medication leaked onto my hand) and inadvertent exposure to vaccine (Verbatim: medication leaked onto my hand). On an unknown date, the patient experienced syringe connection issue (Verbatim: medication leaked out of the prefilled syringe around the plastic) and pharmaceutical product complaint (Verbatim: 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 Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the syringe connection issue to be related to Boostrix and Boostrix 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: 09-MAY-2025 Other healthcare professional reported about a defective prefilled syringe. When she started to administer the injection the medication leaked out of the prefilled syringe around the plastic portion that attaches to the needle. The medication leaked onto reporter's hand and the patient's arm, which led to occupational exposure via skin contact with product, inadvertent exposure to vaccine and syringe connection issue. Needle was securely attached to the syringe. This case is linked with US2025057149 reported by same reporter for the patient.; Sender's Comments: US-GSK-US2025057149:Same reporter/Diffrent patient