Received Sep 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | h4k3s | — |
extra needle stick; administer a dose of BOOSTRIX to a patient, she could not depress the plunger; Syringe isue; Defect was discovered after partial use of the box - this was the last dose in the box.; This non-serious case was reported by a non-health professional via call center representative and described the occurrence of needle stick/puncture in a adult patient who received DTPa (Reduced antigen) (Boostrix) (batch number h4k3s) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced needle stick/puncture (Verbatim: extra needle stick), accidental underdose (Verbatim: administer a dose of BOOSTRIX to a patient, she could not depress the plunger), syringe issue (Verbatim: Syringe isue) and pharmaceutical product complaint (Verbatim: Defect was discovered after partial use of the box - this was the last dose in the box.). The outcome of the needle stick/puncture was unknown and the outcome of the accidental underdose, syringe issue and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the needle stick/puncture and syringe issue to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the needle stick/puncture and syringe 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: 07-AUG-2025 The reporter was the healthcare professional who stated that a when attempting to administer a dose of Boostrix to a patient, she could not depress the plunger and had to use another dose. The defect was discovered after partial use of the box, this was the last dose in the box. When she encountered the initial resistance, she took the needle out from the patient. After manipulation, she was eventually able to push it. She used a different dose to administer to the patient.