Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | UNK | — | — |
needle stayed in patient's arm; This is a spontaneous report received from a Pharmacist. A patient (age and gender not provided) received respiratory syncytial virus 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 ISSUE (non-serious), outcome "unknown", described as "needle stayed in patient's arm". Additional information: It was reported that the needle stayed in patient's arm. Only luer lock and syringe came back from patient's arm. Reporter was unaware if patient was administered with the product or not, only that, the needle stayed in the patient's arm. Causality for "needle stayed in patient's arm" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The event needle device issue is assessed unrelated to the suspect product, possibly due to the device constituent