Received Mar 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (HIBERIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 395JH | — |
The needle and Luer Lok Adaptor broke off during administration but unknown how much vaccine administered; The needle and Luer Lok Adaptor broke off during administration; Product Complaint; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete dose administered in a patient who received Hib (Hiberix) (batch number 395JH, expiry date 11-DEC-2028) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced incomplete dose administered (Verbatim: The needle and Luer Lok Adaptor broke off during administration but unknown how much vaccine administered), device connection issue (Verbatim: The needle and Luer Lok Adaptor broke off during administration) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the incomplete dose administered, device connection issue and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the device connection issue to be related to Hiberix and Haemophilus Influenzae Type B Vaccine And Diluent. It was unknown if the company considered the device connection issue to be related to Hiberix and Haemophilus Influenzae Type B Vaccine And Diluent. 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: 10-FEB-2025 The reporter reported that Hiberix prefilled syringe luer lok adaptor broke off 3 to 5 times. The reporter believed up to five prefilled syringes were involved but one prefilled syringe discarded, so he was not sure of the total quantity affected. The box discarded so the batch number was not available. The batch number with expiry date from the prefilled syringe picture of the defect has emailed. The reporter asked to confirm that all operations performed appropriately as defect discovered during administration in one instance, the needle and luer lok adaptor broke off during administration and was unknown how much vaccine the patient received. The reporter does not know if the product not administered or partially administered with the other 2 to 4 suspect prefilled syringes. During injection detaching of the luer lok adaptor but previously discarded needles were not available for return to GlaxoSmithKline. One of the suspect prefilled syringes was available for return to GlaxoSmithKline and box, up to four additional suspect prefilled syringes and the needles discarded. The vaccine administration facility was the same as primary reporter.