Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Syringe issue
Clinical narrative: They had a hard time pushing down the plunger; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of SYRINGE ISSUE (They had a hard time pushing down the plunger) 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. 3032262) for COVID-19 prophylaxis.    The suspect product included Pre-filled Syringe injection (batch no. 3032262) for COVID-19 prophylaxis.    No Medical History information was reported.   On 02-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 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 SYRINGE ISSUE (They had a hard time pushing down the plunger) and NO ADVERSE EVENT (No adverse event). At the time of the report, SYRINGE ISSUE (They had a hard time pushing down the plunger) 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 SYRINGE ISSUE (They had a hard time pushing down the plunger).  For Pre-filled Syringe, the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for SYRINGE ISSUE (They had a hard time pushing down the plunger).    No concomitant medications were reported.  They received the PFS vaccine shipment and after one hour had a patient whom they adminsitered the vaccine. They had a hard time pushing down the plunger. They had to stick in 3 different PFS to the patient (from 2 boxes but same lot number) and they were all wasted.  The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which include Use of Device Problem.   Evaluation and Investigation codes included FDA code 4114, IMDRF code B17 Method / type Device Not Returned. FDA code 3221, IMDRF code C20, result/ findings No Findings Available.   No treatment medications were provided.   QUALITY-SAFETY EVALUATION OF PTC: Performed a complete investigation for the Defect/Defect Detail reported of Syringe/Plunger Rod/Unable to push/pull (requires excessive force) for three reported PFS from CMO batch number 3032262 (See the report attached RC-2023-0851 for the investigation performed for the packaging process and RC-153/23-NA performed (JC) for the Filling and AVI PFS process) classified this defect as Major according to their Risk Priority Number. Regarding recurrence, similar complaint related to hard to press the plunger rod received during the last 12 months. excluded Machinery as possible root cause since a poor insertion Of the plunger rod would lead to all the units being affected. A problem with one Of the clamps would lead to the defect appearing recurrently Material was excluded as possible root cause due to Combi machine would catch any defective plunger rods classified this defect as Minor according to their Risk Priority Number. Regarding recurrence, this is the tenth complaint received for the hard to press plunger rod during the last 12 months, therefore this complaint is classified as Recurrent. excluded Environment, Personnel, Method, Measurements, and Machinery as source Of potential root cause. Materials (syringes and stoppers) tested at incoming resulted in no defects or anomalies detected. During the filling process, syringes were inspected every 30 minutes for anomalies and defects with all conforming. During initial inspection, 0.11% were rejected for stopper defects, 0.43% were rejected for particles in stopper or syringe body and 1.18% were rejected for particles in solution of 241, 165 units produced . No defects were detected during the routine second and third inspection sample populations. During release testing, the break up force and gliding force testing conformed to release criteria After the investigations performed, no root cause for the claimed defect could be assigned, therefore this complaint was classified as non- attributable and no CAPA. Performed a complete investigation for the Defect/Defect Detail reported of Syringe/Plunger Rod/Unable to push/pull (requires excessive force) for three reported PFS from CMO batch number 3032262 (See the report attached for the investigation performed for the packaging process and RC-153/23-NA performed (JC) for the Filling and AVI PFS process) classified this defect as Major according to their Risk Priority Number. Regarding recurrence, similar complaint related to hard to press the plunger rod received during the last 12 months. excluded Machinery as possible root cause since a poor insertion Of the plunger rod would lead to all the units being affected. A problem with one Of the clamps would lead to the defect appearing recurrently Material was excluded as possible root cause due to Combi machine would catch any defective plunger rods classified this defect as Minor according to their Risk Priority Number. Regarding recurrence, this is the tenth complaint received for the hard to press plunger rod during the last 12 months, therefore this complaint is classified as Recurrent. excluded Environment, Personnel, Method, Measurements, and Machinery as source Of potential root cause. Materials (syringes and stoppers) tested at incoming resulted in no defects or anomalies detected. During the filling process, syringes were inspected every 30 minutes for anomalies and defects with all conforming. During initial inspection, 0.11% were rejected for stopper defects, 0.43% were rejected for particles in stopper or syringe body and 1.18% were rejected for particles in solution of 241, 165 units produced . No defects were detected during the routine second and third inspection sample populations. During release testing, the break up force and gliding force testing conformed to release criteria After the investigations performed, no root cause for the claimed defect could be assigned, therefore this complaint was classified as non- attributable and no CAPA.   Most recent FOLLOW-UP information incorporated above includes: On 03-Oct-2023: Live Follow-up received contains PQC report added and reference numbers added. On 11-Jan-2024: Significant follow-up received on 11-Jan-2024: QC result and QC result date added.