SYRINGE 5ML SALINE FILL CHINA SP

Additional Manufacturer Narrative

THERE ARE NO SAMPLES RETURNED, SO IT IS IMPOSSIBLE TO INFER THE POSSIBLE CAUSE. THE MOST LIKELY ROOT CAUSE OF THIS DEFECT IS LEAKAGE RESULTING FROM UNCERTAIN EXTERNAL FORCES APPLIED TO THE PRODUCT. THE FACTORY HAS INITIATED CAPA TO CONDUCT A SYSTEMATIC INVESTIGATION INTO PREVIOUS LEAKAGE COMPLAINTS. CORRECTIVE MEASURES HAVE BEEN FORMULATED AND IMPLEMENTED AND ARE NOW IN THE STAGE OF EFFECTIVENESS VERIFICATION. THE FOLLOWING CORRECTIVE MEASURES HAVE BEEN TAKEN: AN AIR BLOWING DEVICE IS ADDED AT THE POSITION OF THE DISTRIBUTOR TO ENSURE THAT NO PRODUCTS WILL BE STUCK AT THE DISPLACED POSITION. WHEN THE PRODUCT IS COMPRESSED, AN ALARM WILL BE TRIGGERED AND ALL THE PRODUCTS FROM THE DISTRIBUTOR TO THE STAR WHEEL OF THE FLOW WRAP SHOULD BE CHECKED. A VISUAL AIDS DOCUMENT WILL BE ESTABLISHED TO ADD THIS REQUIREMENT. REPLACE THE SENSOR FOR DETECTING THE HEIGHT OF THE PRODUCT. WHEN THE PLACEMENT POSITION OF THE PRODUCT IS OFFSET, THE VACUUM CUP SKIPS IT. STANDARDIZE THE PLUNGER ROD ASSEMBLY MACHINE FEEDING STAR WHEEL ALIGNMENT AND INSPECTION OF ALIGNMENT EFFECTIVENESS. A VISUAL AIDS DOCUMENT WILL BE ESTABLISHED TO ADD THIS REQUIREMENT. PERFORM SHIFT INSPECTIONS ON THE ALIGNMENT OF THE STAR WHEEL AT THE FEEDING SECTION OF THE CORE ROD ASSEMBLY EQUIPMENT. THE ONGOING VALIDATION PLAN FOR EFFECTIVENESS IS AS FOLLOWS: SINCE THE NUMBER OF COMPLAINTS FOR THE 10 ML PRODUCT IS HIGHER THAN OTHER SPECIFICATIONS, THREE BATCHES OF 10 ML WILL BE TRACKED. DURING THE PACKAGING PROCESS, THE INSPECTION FREQUENCY WILL BE INCREASED TO SAMPLE ONE BOX EVERY HALF HOUR, AND A VISUAL INSPECTION WILL BE CONDUCTED TO ENSURE THERE IS NO LEAKAGE.

Description of Event or Problem

NO ADDITIONAL INFORMATION PROVIDED.

Additional Manufacturer Narrative

H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

THE PRE-FILLED CATHETER FLUSHER USED BY THE RESPONSIBLE NURSE EXHIBITED LEAKAGE OF FLUID FROM THE PACKAGING UPON OPENING AND SHOULD NOT BE USED.