BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 9438602 · Received December 9, 2019

    Report

    Report Number
    9610847-2019-00721
    Event Type
    Malfunction
    Date Received
    December 9, 2019
    Date of Event
    November 19, 2019
    Report Date
    February 6, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903097037
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY : A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE PROVIDED LOT NUMBER 9091753 AND THE APPLICABLE SUB-ASSEMBLY LOT NUMBERS (9042839 & 9044873). LOT NUMBER 9042839 WAS PRODUCED WITHOUT ANY QUALITY NOTIFICATIONS AND ALL INSPECTIONS WERE ACCEPTED. DURING THE PRODUCTION OF LOT NUMBER 9044873, A QUALITY NOTIFICATION WAS ISSUED AND PRODUCTION WAS PUT ON HOLD. SAMPLING WAS PERFORMED TO ENSURE THAT ALL DEFECTIVE PRODUCT WAS DETECTED PRIOR TO RELEASE FOR LOT NUMBER 9044873 AND FINAL INSPECTIONS WERE FOUND ACCEPTABLE. THE FINAL PRODUCT LOT NUMBER, 9091753, DISPLAYED NO QUALITY ISSUES DURING PRODUCTION AND ALL INSPECTIONS WERE FOUND TO BE WITHIN SPECIFICATION. TO FURTHER INVESTIGATE THIS INCIDENT, BOTH PICTURE SAMPLES AND PHYSICAL SAMPLES WERE RETURNED FOR INVESTIGATION. THROUGH EXAMINATION OF THE PICTURE SAMPLES, LEAKAGE WAS OBSERVED PAST THE SECOND RIB OF THE SYRINGE STOPPER. THREE PLASTIC BAGS OF SIX USED SYRINGES EACH LABELED AS LOT NUMBER 9091753 WERE RECEIVED. THROUGH EXAMINATION OF THE BAGGED SAMPLES, LEAKAGE WAS OBSERVED PAST THE STOPPER IN EACH OF THE SYRINGES. SOME OF THE SYRINGES APPEARED TO HAVE FLANGE DAMAGE; HOWEVER, NONE OF THE SYRINGES EXHIBITED FOREIGN MATTER IN THE FLUID PATHWAY OR WITHIN THE STOPPER RIBS. ONE SYRINGE HAD A STRAND OF PLASTIC NEAR THE FLANGE AREA WHERE IT APPEARED TO BE DAMAGED. TWO SEALED CONVENIENCE TRAYS BELONGING TO LOT 9091753 WERE ALSO RECEIVED FOR EVALUATION. THE FIRST TRAY WAS EXAMINED AND TEN OF THE SYRINGES HAD DAMAGE TO THE INNER FLANGE AREA. THESE TEN SYRINGES WERE FOUND TO HAVE PLASTIC FOREIGN MATTER OUTSIDE OF THE FLUID PATHWAY BEHIND THE STOPPER, WHICH WAS LIKELY A RESULT OF THE FLANGE DAMAGE. THE REMAINING SYRINGES SHOWED NO DEFECTS. THE SECOND TRAY WAS EXAMINED AND FOUR OF THE SYRINGES HAD DAMAGE TO THE INSIDE OF THE FLANGE AREA. THESE FOUR SYRINGES WERE ALSO FOUND TO HAVE PLASTIC FOREIGN MATTER OUTSIDE OF THE FLUID PATHWAY BEHIND THE STOPPER, LIKELY CAUSED BY THE FLANGE DAMAGE. THE REMAINING SYRINGES SHOWED NO DEFECTS. EACH OF THE UNUSED SYRINGES WERE FUNCTIONALLY TESTED AND LEAKAGE WAS NOT OBSERVED PAST THE SYRINGE STOPPER. IT IS POSSIBLE THAT THE SYRINGES WERE AFFECTED BY THE QUALITY NOTIFICATION ISSUED FOR SUB-ASSEMBLY LOT 9044873. ALTHOUGH THE RETURNED SAMPLES DID NOT DISPLAY THIS DEFECT, IT IS POSSIBLE THAT THE FLANGE DAMAGE RESULTED IN LOOSE PLASTIC FOREIGN MATTER THAT BECAME PLACED BETWEEN THE BARREL WALL AND THE STOPPER, FORMING A CHANNEL FOR LEAKAGE IN A SMALL NUMBER OF SYRINGES. A CORRECTIVE ACTION AND PREVENTIVE ACTION PLAN HAS BEEN INITIATED TO FURTHER INVESTIGATE AND PREVENT THE ISSUE OF FLANGE DAMAGE AND FOREIGN MATTER. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS DEFECT IN ADDITION TO THE EXTRA STEPS TAKEN THROUGH THE ACTION PLAN.

    Description of Event or Problem · 0

    MATERIAL NO. 309680, BATCH NO. 9091753. IT WAS REPORTED THAT BEFORE USE OF THE SYRINGE 5ML LL TIP BULK CONVENIENCE PAK THE SYRINGES ARE LEAKING FROM THE PLUNGER. 517 SYRINGES WERE FOUND TO HAVE THE LEAKAGE ISSUE. I HAVE A CUSTOMER THAT ORDERS THE ITEM REFERENCE # 309680. THEY HAVE SEVERAL SCAR'S IN PLACE RIGHT NOW REGARDING LEAKING SYRINGES. THEY HAVE IDENTIFIED A COUPLE MORE LOTS OF THE BD SYRINGES THAT ARE LEAKING FROM THE PLUNGER. THE CUSTOMER WOULD LIKE TO SCHEDULE A PHONE CALL SO THEY CAN DISCUSS A PLAN AS WELL AS THIS ISSUE. THEY REALLY WOULD LIKE THIS TAKEN CARE OF BECAUSE THEY DON'T WANT IT TO IMPACT THEIR PRODUCT MORE THAN IT ALREADY HAS. SCAR DETAILS: 517 LEAKING SYRINGES FOUND DURING VISUAL INSPECTION OF FINISHED PRODUCT. SYRINGES LEAKING FROM UNDER THE SAFETY SEAL.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 309680, BATCH NO. 9091753. IT WAS REPORTED THAT BEFORE USE OF THE SYRINGE 5ML LL TIP BULK CONVENIENCE PAK THE SYRINGES ARE LEAKING FROM THE PLUNGER. 517 SYRINGES WERE FOUND TO HAVE THE LEAKAGE ISSUE. I HAVE A CUSTOMER THAT ORDERS THE ITEM REFERENCE # 309680. THEY HAVE SEVERAL SCAR'S IN PLACE RIGHT NOW REGARDING LEAKING SYRINGES. THEY HAVE IDENTIFIED A COUPLE MORE LOTS OF THE BD SYRINGES THAT ARE LEAKING FROM THE PLUNGER. THE CUSTOMER WOULD LIKE TO SCHEDULE A PHONE CALL SO THEY CAN DISCUSS A PLAN AS WELL AS THIS ISSUE. THEY REALLY WOULD LIKE THIS TAKEN CARE OF BECAUSE THEY DON'T WANT IT TO IMPACT THEIR PRODUCT MORE THAN IT ALREADY HAS. SCAR DETAILS: 517 LEAKING SYRINGES FOUND DURING VISUAL INSPECTION OF FINISHED PRODUCT. SYRINGES LEAKING FROM UNDER THE SAFETY SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236965 SYRINGE 5ML LL TIP BULK CONVENIENCE PAK PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 309703 9091753 30382903097037

    Patients

    Seq Age Sex Outcome Treatment
    1 Other