Received Feb 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 3043259 | — |
Facing issues with the stopper of the syringe as it takes too much twisting and hard to get them off without wasting any medication.; No adverse effect; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE USE ISSUE (Facing issues with the stopper of the syringe as it takes too much twisting and hard to get them off without wasting any medication.) 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. 3043259) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3043259) 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) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE USE ISSUE (Facing issues with the stopper of the syringe as it takes too much twisting and hard to get them off without wasting any medication.) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE USE ISSUE (Facing issues with the stopper of the syringe as it takes too much twisting and hard to get them off without wasting any medication.) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. Concomitant medication was not provided. It was reported that healthcare professional faced issues with the stopper of the syringe as it took too much twisting and hard to get it off without wasting any medication. As per pharmacist there was no issue administering the vaccine to patients. Treatment information was not reported. The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which include Use of Device Problem. Investigation Code Information FDA Code: 4112, IMDRF Code: B15, Method/Type: Analysis of Data Provided by User/Third Party, FDA Code: 4248, IMDRF Code: C23, Result/Findings: Usage Problem Identified, FDA Code: 4310, IMDRF Code: D10, Conclusion: Caused traced to non-device related factors. FDA Code: 4110, IMDRF Code: B12, Method/Type: Trend Analysis, Analysis of Data Provided by User/Third Party, FDA Code: 3221, IMDRF Code: C20, Result/Findings: No Findings Available, FDA Code: 4310, IMDRF Code: D10, Conclusion: Caused traced to non-device related factors. QUALITY-SAFETY EVALUATION OF PTC: A healthcare provider (HCP) contacted the Contact Center regarding hard to remove stoppers. Based on the pre-filled syringe (PFS) diagram, the HCP was complaining about the rubber tip cap/rigid cap, not stopper. Immediate Actions: The call agent forwarded the case to the Drug Safety team, and a safety database number was provided. The complaint was forwarded to the Product Quality Complaint team for further review. Investigation: Previous investigations were carried out by Schott for hard to remove tip cap from the PFS, and although it was for different batch numbers, it was concluded that no root cause was found at Schott. However, the RC was most likely related to the end user who did not correctly unscrew the PFS. The tip cap mechanism has an elastic strain when unscrewing, and the end user needs to continue unscrewing, in a linear, slow and steady motion, without applying pulling forces, to overcome this strain and properly open the PFS. For correct opening of the TRC, Pharma highly recommends unscrewing slowly and steadily, in a straight line and without the use of pulling force. Schott Pharma provided with an "Instruction manual for TRC opening" (see attachments). The correct opening instructions are available to HCPs via this Moderna link: A Memo was written by Technical Development team (see QD ref. "PFS Assessment of factors influencing tip cap removal force" (MEMO-10713)), concluding that the tip cap removal force meets the performance requirements of the device and the user requirements. Risks associated with tip cap removal are reduced as far as possible. The tip cap removal force provides an acceptable user experience. A trend analysis was performed for the last 12 months for this defect and the batch in question (3043259) did not exceed the action limit (3 standard deviat Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2024: Live non-significant follow up received and added references. On 11-Dec-2024: Significant follow up received : close PQC received,