SYRINGE 10ML SALINE FILL CHINA SP

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. IN THIS MDR, BD COLUMBUS, NE HAS BEEN LISTED IN SECTIONS D.3. AND G.1. DEVICE(S) MANUFACTURED IN A FACILITY THAT DOES NOT MANUFACTURE DEVICES FOR THE US MARKET.

Description of Event or Problem

THE PRODUCT WAS FOUND TO HAVE LEAKAGE INSIDE THE PACKAGING BEFORE OPENING.

Description of Event or Problem

NO ADDITIONAL INFORMATION PROVIDED.

Additional Manufacturer Narrative

SINCE NO SAMPLE WAS AVAILABLE FOR RETURN AND NO PICTURES WERE RETAINED, THE DEFECT REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. 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, ESTABLISH A VISUAL AIDS DOCUMENT TO ADD THE 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 PLUNGER ROD ASSEMBLY MACHINE IN FEEDING STAR WHEEL ALIGNMENT AND INSPECTION ON ALIGNMENT EFFECTIVENESS, ESTABLISH A VISUAL AIDS DOCUMENT TO ADD THE 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 MORE THAN OTHER SPECIFICATIONS, THREE BATCHES OF 10 ML WILL BE TRACKED. DURING THE PACKAGING PROCESS, THE INSPECTION FREQUENCY WILL BE INCREASED, SAMPLING ONE BOX EVERY HALF AN HOUR, AND CONDUCTING A VISUAL CHECK TO ENSURE THERE IS NO LEAKAGE.