Received Mar 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | HM9865 | — |
Abrysvo were not working correctly/the old ones where the diluent was screwed on and put in the diluent and pulled it out and it just broke off; This is a spontaneous report received from an Other HCP from product quality group,. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Lot number: HM9865, Expiration Date: 30Apr2025) for immunisation, Device Lot Number: HG1756, Device Expiration Date: 31May2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE DEFECTIVE (non-serious), outcome "unknown", described as "Abrysvo were not working correctly/the old ones where the diluent was screwed on and put in the diluent and pulled it out and it just broke off". Additional information: Reporter had a box from previous, the old ones where the diluent was screwed on and put in the diluent and pulled it out and it just broke off. They had 2 in a box where this happened. Reporter clarified that it just broke off - on top, it had a metal part inside, so the top of the metal part, like where the actual vial was put to put the diluent in the little syringe part. It was on top of the vial, it was metal, and on top, there was a plasticky glass where the syringe went in and pulled back out. It was the plasticky part that went on. The syringe was okay; it was the syringe that it went into the end that sticks out. It came with a syringe and vial. Causality for "abrysvo were not working correctly/the old ones where the diluent was screwed on and put in the diluent and pulled it out and it just broke off" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). No follow-up attempts are possible.