Received Jun 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (MRESVIA) | MODERNA | UNK | 3041772 | IM |
removing the cap (where the needle is located) was also hard to remove; the vaccine's plunger was "very hard" to push when the HCP administered the vaccine/ the plunger was extremely heavy and was hard to push/issue with the plunger being extremely heavy; No adverse effect; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE DIFFICULT TO USE (removing the cap (where the needle is located) was also hard to remove), DEVICE ISSUE (the vaccine's plunger was "very hard" to push when the HCP administered the vaccine/ the plunger was extremely heavy and was hard to push/issue with the plunger being extremely heavy) and NO ADVERSE EVENT (No adverse effect) in a 68-year-old female patient who received mRNA-1345 (mRESVIA) (batch no. 3041772) for Respiratory syncytial virus infection prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3041772) for Respiratory syncytial virus infection prophylaxis. No Medical History information was reported. On 17-Jun-2025, the patient received dose of mRNA-1345 (mRESVIA) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE DIFFICULT TO USE (removing the cap (where the needle is located) was also hard to remove), DEVICE ISSUE (the vaccine's plunger was "very hard" to push when the HCP administered the vaccine/ the plunger was extremely heavy and was hard to push/issue with the plunger being extremely heavy) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE DIFFICULT TO USE (removing the cap (where the needle is located) was also hard to remove), DEVICE ISSUE (the vaccine's plunger was "very hard" to push when the HCP administered the vaccine/ the plunger was extremely heavy and was hard to push/issue with the plunger being extremely heavy) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. For mRNA-1345 (mRESVIA) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. No concomitant medications were reported. HCP mentioned that they encountered a plunger error on a syringe that was administered to a patient. HCP reported that the vaccine's plunger was heavy and was very hard to push and removing the cap, where the needle was located was also hard to remove. HCP wanted a product replacement on a syringe they used to administer to a patient. HCP reported that was successfully administered to a patient. It was reported that only one syringe was used and only one patient received the vaccine. A possible occupational exposure of vaccine during administration due to plunger problem was considered. No adverse events were reported after the vaccination. No treatment medications were reported. The Device Problem Information include FDA code: 1670, IMDRF Code: A23, Device problem: Use of Device Problem. Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2025: Live Follow up received that contains non-significant information and reference ID added. On 17-Jun-2025: Live Follow up received contains non-significant information and reference ID added. On 17-Jun-2025: Live Follow up received contains non-significant information and reference ID added. On 17-Jun-2025: Live follow-up received contains significant information and reporter details updated, patient details updated, new event added, narrative updated, reference ID added On 18-Jun-2025: Live Follow up received that contains non-significant information and reference ID added. On 18-Jun-2025: Live Follow-up received contains significant information and event LLT updated, Reference ID added.