once the pharmacy tried to reconstitute it, it broke/something went wrong with the component of the diluent syringe; needle broke off the diluent syringe; This is a spontaneous report received from an Other HCP 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: KC7884, Expiration Date: 30Sep2025) for immunisation, Device Lot Number: HM8389, Device Expiration Date: Sep2025. 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 “once the pharmacy tried to reconstitute it, it broke/something went wrong with the component of the diluent syringe”; NEEDLE ISSUE (non-serious), outcome “unknown”, described as “needle broke off the diluent syringe”. Causality for “once the pharmacy tried to reconstitute it, it broke/something went wrong with the component of the diluent syringe” and “needle broke off the diluent syringe” was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). Additional information: Has a caller on the line who is a pharmacy intern calling about Abrysvo vaccine and stated that once the pharmacy tried to reconstitute it, it broke. She is reporting that and requests replacement product. The presentation is the diluent and the lyophilized antigen component. She is not fully aware what happened regarding it breaking but the pharmacist told her that while trying to reconstitute it, the needle broke off the diluent syringe and she has no manufacturer name or lot number to provide for the needle. Caller clarified she is now not sure if the needle broke or if something went wrong with the component of the diluent syringe. Carton/box: lot number KC7884, expiry date Sep2025, NDC 0069034401; Antigen vial: lot number KC7884, expiry date Oct2025, NDC 0069020701, and it says lyophilized antigen component. Diluent syringe: lot number HM8389, expiry date Sep2025, NDC 0069025001. Vial adaptor: Asks is that the white portion and she sees the connector piece on the diluent and antigen vial. Confirmed no patient involvement.