Received Dec 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | UNK | LG9827 | — |
The top part broke off when they were trying to attach the needle / broken glass observed for Abrysvo; The initial case was missing the following minimum criteria: product complaint only. Upon receipt of follow-up information on 25Nov2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Pharmacist from product quality group, Program ID: . A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: LG9827, Expiration Date: 31Oct2025) for 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 "The top part broke off when they were trying to attach the needle / broken glass observed for Abrysvo". Product Quality Group provided investigational results on 25Nov2025 for rsv vaccine prot.subunit pref 2v (device constituent): The complaint for "the top part broke off when they were trying to attach the needle" of "Abrysvo" was investigated. The investigation included reviewing the involved batch records, deviation investigation, complaint sample, an analysis of the complaint history for the involved scope and Annual Product Review. The reported defect was present on the returned complaint sample. 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. The Issue Escalation (NTM) process determined that no regulatory notification was required. The final scope was determined to be the associated lots of the reported lot LG9827. 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 Report. The Complaint Issue "Luer Lock Detached During Prep/Use" was reported. 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 is no current trend alert documented.