Received Feb 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | LP1776 | — |
One of the vials was damaged/one of the vials was broken/They have not administered it; This is a spontaneous report received from a Consumer or other non HCP from product quality group. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), (Lot number: LP1776, Expiration Date: 26Apr2025) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "One of the vials was damaged/one of the vials was broken/They have not administered it". The action taken for BNT162b2 omicron (kp.2) was unknown. Additional information: One of their vaccines that they received from Pfizer, she realized that one of the vials was damaged. They have not administered it or utilized it. She just realized that one of the vials was broken when she unboxed that. The vaccine was not administered to any patient. They are looking to either return it or get it replaced or get credit. Causality for "one of the vials was damaged/one of the vials was broken/they have not administered it" was determined associated to device constituent of BNT162b2 omicron (kp.2) (malfunction). Product Quality Group provided investigational results on 17Feb2025 for bnt162b2 omicron (kp.2) (device constituent): The complaint for "one of the vials was broken when she unboxed that" of Comirnaty PFS was investigated. The investigation included reviewing the involved batch records, deviation investigation, a picture of the complaint sample, evaluation of retain sample and an analysis of the complaint history for the involved scope and Annual Product Review. Quantity of returned complaint sample: picture. The reported defect was present on the returned complaint sample picture. The complaint is confirmed. No root cause or CAPA were identified as all reviewed records in scope of this investigation met the established requirements at time of release. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. The final scope was determined to be the associated lots of the reported lot LP1776. The reported defect is not representative of the quality of the batch, and reported lot remains acceptable for further distribution. Device Investigation: This investigation is based on the information captured in the Complaint Description and Argus Report. The Complaint Issue "Luer Lock Detached During Prep/Use" was reported. The complaint issue is selected as per the sample. The Risk Management File was reviewed to confirm that the Hazard(s) and Hazardous Situation(s) associated with the Complaint Issue are documented in the Hazard Analysis. All complaint investigations are trended. There no current trend alert documented.