Received Feb 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 8146751 | IM |
a PFS that had the rigid cap separating from the rubber tip while she was removing it. She said that the rigid cap was in her hand while the rubber tip remained on the syringe and she was not able to use that PFS; MIS reporting this as a near miss AE/this patient did not receive the prefilled syringe that had the malfunctioning rubber tip/rigid cap.; a PFS that had the rigid cap separating from the rubber tip while she was removing it. She said that the rigid cap was in her hand while the rubber tip remained on the syringe and she was not able to use that PFS; No adverse effect; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE USE ISSUE (a PFS that had the rigid cap separating from the rubber tip while she was removing it. She said that the rigid cap was in her hand while the rubber tip remained on the syringe and she was not able to use that PFS), INTERCEPTED PRODUCT ADMINISTRATION ERROR (MIS reporting this as a near miss AE/this patient did not receive the prefilled syringe that had the malfunctioning rubber tip/rigid cap.), PRODUCT CLOSURE REMOVAL DIFFICULT (a PFS that had the rigid cap separating from the rubber tip while she was removing it. She said that the rigid cap was in her hand while the rubber tip remained on the syringe and she was not able to use that PFS) and NO ADVERSE EVENT (No adverse effect) in a patient of an unknown age and gender who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 8146751) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 8146751) for COVID-19 prophylaxis. No Medical History information was reported. On 28-Nov-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE USE ISSUE (a PFS that had the rigid cap separating from the rubber tip while she was removing it. She said that the rigid cap was in her hand while the rubber tip remained on the syringe and she was not able to use that PFS), INTERCEPTED PRODUCT ADMINISTRATION ERROR (MIS reporting this as a near miss AE/this patient did not receive the prefilled syringe that had the malfunctioning rubber tip/rigid cap.), PRODUCT CLOSURE REMOVAL DIFFICULT (a PFS that had the rigid cap separating from the rubber tip while she was removing it. She said that the rigid cap was in her hand while the rubber tip remained on the syringe and she was not able to use that PFS) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE USE ISSUE (a PFS that had the rigid cap separating from the rubber tip while she was removing it. She said that the rigid cap was in her hand while the rubber tip remained on the syringe and she was not able to use that PFS), INTERCEPTED PRODUCT ADMINISTRATION ERROR (MIS reporting this as a near miss AE/this patient did not receive the prefilled syringe that had the malfunctioning rubber tip/rigid cap.), PRODUCT CLOSURE REMOVAL DIFFICULT (a PFS that had the rigid cap separating from the rubber tip while she was removing it. She said that the rigid cap was in her hand while the rubber tip remained on the syringe and she was not able to use that PFS) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (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 reported about a PFS that had the rigid cap separating from the rubber tip while she was removing it. She said that the rigid cap was in her hand while the rubber tip remained on the syringe and she was not able to use that PFS. She stated that she was preparing the syringe to be used on a patient, reporting that as a near miss AE. The rigid cap separated from the rubber tip, rendering the syringe unusable. Upon follow up, it was reported that the patient did not receive the prefilled syringe that had the malfunctioning rubber tip/rigid cap. This PFS vaccine was not used on any patient and had been quarantined from the vaccine supply and marked as to not use in future. The patient did receive a new Spikevax PFS vaccine that functioned properly; and no adverse events observed at that time. The Device problem code for pre-filled syringe also included FDA code 1670, IMDRF code A23 which included Use of Device Problem. Evaluation/ investigation code information included FDA Code 4112, IMDRF Code B15 by using method as analysis of data provided by user/third party; result/findings included FDA Code 114, IMDRF Code C13 for Operational Problem Identified; conclusion included FDA Code 19, IMDRF Code D11 for Cause Traced to User. No treatment information was provided. QUALITY-SAFETY EVALUATION OF PTC: Investigation Summary & Conclusion with Root Cause Details: It was reported that the Technical Development team confirmed that the tip cap removal force met performance and user requirements, with no manufacturing defects found. The likely cause of issues was user handling errors. A 12-month trend analysis showed no signals for this defect. As a result, no Corrective and Preventive Action (CAPA) was recommended currently, but the situation continued to be monitored for any emerging trends. Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2026: Follow up received which contains significant information, closed PQC investigation report received in which QC result, QC result date was added and narrative was updated.