Received Jun 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | UNK | — | — |
Had a defect; It broke; The person was not able to use the vaccine; The vial broke; The initial case was missing the following minimum criteria: not reportable product complaint. Upon receipt of follow-up information on 23Jun2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Physician from product quality group. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), described as "Had a defect; It broke; The person was not able to use the vaccine; The vial broke". Additional information: a sales representative reported that a customer that had the rsv vaccine prot.subunit pref 2v and when they were about to administer it, however, they had a defect with the vaccine. When they were reconstituting one of their rsv vaccine prot.subunit pref 2v vaccines, it did not reconstitute, and it messed up the bottle. The customer was unable to administer, as they thought it broke. The reporter stated that was the defect that happened, and the person was not able to use the vaccine. It was further reported, "while they were administering it, there occurred an issue, where the vial broke. She was with the customer that time." It was clarified that the defective product was not given to any patient. The reporter considered "had a defect; it broke; the person was not able to use the vaccine; the vial broke" not related to rsv vaccine prot.subunit pref 2v. Causality for "had a defect; it broke; the person was not able to use the vaccine; the vial broke" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). Product Quality Group provided investigational results on 03Mar2025 for rsv vaccine prot.subunit pref 2v (device constituent): Investigation Summary and Conclusion: (withheld) 03Mar2025. No further investigation was required as no valid lot number or returned sample was available. This complaint will continue to be trended. If additional information becomes available, this complaint will be reopened.