Sex: U
Vaccine: COVID19
Symptoms: Device occlusion, No adverse event
Clinical narrative: Plunger got stuck. Could not push it up at all and it would not budge.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE OCCLUSION (Plunger got stuck. Could not push it up at all and it would not budge.) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030536) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection (batch no. 3030536) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE OCCLUSION (Plunger got stuck. Could not push it up at all and it would not budge.) and NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE OCCLUSION (Plunger got stuck. Could not push it up at all and it would not budge.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for DEVICE OCCLUSION (Plunger got stuck. Could not push it up at all and it would not budge.).  For Pre-filled Syringe, the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for DEVICE OCCLUSION (Plunger got stuck. Could not push it up at all and it would not budge.).    Reporter need to report an issue with Spikevax syringe for which plunger got stuck. Reporter could not push it up at all and it would not budge. Reporter was trying to inject the vaccine syringe into the patient. The Device problem code for Spikevax syringe include FDA code, IMDRF code which include Use of Device Problem. Evaluation / Investigation Code Information include FDA code, IMDRF code which include Analysis of Production Records Result: FDA code, IMDRF code which include usage problem identified. Conclusion: FDA code, IMDRF code which include conclusion not established. The Spikevax syringe device was malfunctioned, and the type was Not CIRM. Concomitant medications were not reported.  No treatment information was provided by the reporter.   QUALITY-SAFETY EVALUATION OF PTC: In response to the SCAR-000148 related to the complaint QE-030407 the investigation, to investigate the PFS packaging process, and the investigation, to investigate the Filling and AVI PFS process, were carried out. The issue raised was about the plunger rod hard to push for one PFS with batch number 3030536.  The company investigation process was focused on review of the batch documentation and the production logbook. All packaging processes were found to be satisfactory, and no events linked to settings or incidents that could have resulted in the claimed defect were reported on the line logbook. All elegance test carried out overall packaging of the claimed batch were satisfactory.  In the investigation performed by company main steps executed during the steps carried out at site which could potentially lead to a hard plunger due to the presence of any particle inside the syringe or a wrong stopper have been reviewed, not finding any incident related to claimed defect. The investigation has not determined any documental evidence which could lead to hard plunger claimed defect. It was concluded that the force needed to press the plunger is a subjective feeling that depends on the user.  Therefore, the cause of the defect was not found to be attributable to the packaging process of the and the filling and AVI process.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2024: Follow-up received with closed PQC report: QC date and result added and narrative updated.