Received Jan 16, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 2TP34 | — |
needle was stuck in the patient; needle issue; syringe broken; product complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental needle stick in a patient who received DTPa-HBV-IPV (Pediarix) (batch number 2TP34, expiry date 19-SEP-2027) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced accidental needle stick (Verbatim: needle was stuck in the patient), needle broken (Verbatim: needle issue), syringe broken (Verbatim: syringe broken) and pharmaceutical product complaint (Verbatim: product complaint). The outcome of the accidental needle stick was not reported and the outcome of the needle broken, syringe broken and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the accidental needle stick, needle broken and syringe broken to be related to Pediarix and Pediarix Pre-Filled Syringe Device. It was unknown if the company considered the accidental needle stick, needle broken and syringe broken to be related to Pediarix and Pediarix 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: 08-JAN-2026 The reporter stated that the same issue had occurred with the same product and the same lot number. The reporter stated that this PQC involved three unknown medical assistants and that they had referred to a previous PQC filed. The reporter stated that the top of the prefilled syringe had completely broken off above the syringe body. While pulling the needle out of the patient, the tip, including the needle, had broken and the needle had become stuck in the patient. The medical assistant had to set the broken syringe down and remove the needle from the patient's leg. The reporter stated that this PQC involved 23 doses. The reporter stated that one of the doses had been successfully administered. The reporter stated that credit would be requested for 22 doses. The reporter stated that all 23 prefilled syringes were available for return. The reporter stated that one prefilled syringe had a needle to be returned. The reporter stated that detachment had occurred while taking the needle out of the patient's body. The reporter stated that the type of needle used had been a Safety Needle, Henry Schein, 25 gauge, 1-inch. The reporter stated that the needle involved was available for return and that, if the needles used were still available, they should be returned along with the other components. The reporter confirmed that there was a product complaint to report. The batch number was not provided and unable to contact the reporter.