Received Jul 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 3046734 | IM |
white plunger part were disconnected from the rubber part of the plunger; No adverse effect; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE ISSUE (white plunger part were disconnected from the rubber part of the plunger) and NO ADVERSE EVENT (No adverse effect) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046734) for COVID-19 prophylaxis. Suspect product included Pre-filled Syringe injection (batch no. 3046734) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (white plunger part were disconnected from the rubber part of the plunger) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (white plunger part were disconnected from the rubber part of the plunger) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. No concomitant medication was reported. It was mentioned that the white plunger part was disconnected from the rubber part of the plunger (this happened when their customer was getting a syringe from the box and plunger fell off and was disconnected). it was reported that filed an adverse event as a possible occupational exposure of the product to the HCP while preparing for administration. The Device problem code for pre-filled syringe include FDA code, code which included Use of Device Problem. No treatment information was reported.