Received Jul 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 9JT4S | — |
issue the plastarea on which we turn the needle into to tighten the hub down, both had cracked; Medication Dispensing Error; one dose was not fully administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9JT4S, expiry date 21-FEB-2027) for prophylaxis. This case was associated with a product complaint. On 01-JUL-2025, the patient received Boostrix. On 01-JUL-2025, an unknown time after receiving Boostrix, the patient experienced underdose (Verbatim: one dose was not fully administered). On an unknown date, the patient experienced syringe issue (Verbatim: issue the plastarea on which we turn the needle into to tighten the hub down, both had cracked) and pharmaceutical product complaint (Verbatim: Medication Dispensing Error). The outcome of the underdose, syringe issue and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the syringe issue to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the 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: 09-JUL-2025,10-JUL-2025 Other HCP reported that a Product Quality Complaint, because two vials of the Boostrix vaccine had an issue the plastic area on which we turn the needle into to tighten the hub down, both had cracked. The medication was squirted everywhere. Also mentioned one dose was not fully administered, and we had to poke the patient again. Reporter reported a PQC because two Boostrix vaccine had an issue the plastic area on which we turn the needle into to tighten the hub down, both have cracked. The medication was squirted everywhere. HCP also mentioned one dose was not fully administered, and they had to poke the patient again. On the other dose, they noticed this issue before administering to the patient. Both suspect syringes were saved. A picture will be sent because when they hold it up to the light we can see a hairline crack at the plastic sheath hub round base with threads/Luer Lock Adaptor. Suspect product was administered for one syringe and no for the other. Luer Lock compatible needle was used. The actual needles that were used on these two syringes have been put in the sharps container however the reporter was willing to send GSK an unopen needle of the same type that was used. It leaked at Luer Lock Adaptor. The one that was being injected into the patient sprayed out in every direction rather than into the patient. The other suspect syringe the leaking was noticed during the removal of the air bubble step, prior to insertion of the needle into he patient. No syringe was pre-assembled with needle some time before administration. Tray and/or box/carton was not damaged. No damage/breakage on the syringe barrel. The leak was not from the plunger stopper. Luer lock was damaged, both syringes LLAs had a hairline crack. If so, describe in detail the needle connection procedure applied: she twists it on until snug she does not force it. Then, she removed the air bubble. Monoject hypodermic safety needle 25-gauge, 1 inch was used.