BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 9525722 · Received December 27, 2019

    Report

    Report Number
    9610847-2019-00771
    Event Type
    Malfunction
    Date Received
    December 27, 2019
    Date of Event
    November 13, 2019
    Report Date
    February 21, 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 FINAL LOT NUMBER 9091753 AND THE SUB-ASSEMBLY PRODUCT LOT NUMBERS 9042839 AND 9044873. DURING THE PRODUCTION PROCESS OF SUB-ASSEMBLY LOT NUMBER 9042839, THERE WERE NO QUALITY ISSUES DETECTED AND ALL INSPECTIONS WERE WITHIN SPECIFICATION. DURING THE PRODUCTION PROCESS OF SUB-ASSEMBLY LOT NUMBER 9044873, A QUALITY NOTIFICATION WAS RAISED FOR THE ISSUE OF FOREIGN MATTER. IN RESPONSE TO THE QUALITY NOTIFICATION, ALL AFFECTED PRODUCT WAS HELD FOR INSPECTION BEFORE RELEASE. DURING THE FINAL PACKAGING PROCESS, NO QUALITY ISSUES WERE DETECTED FOR FINAL LOT NUMBER 9091753. TO FURTHER INVESTIGATE THIS INCIDENT, BOTH PHYSICAL SAMPLES AND PICTURE SAMPLES WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE SAMPLES, LEAKAGE WAS OBSERVED PAST THE SECOND RIB OF THE STOPPER COMPONENT. THREE ZIPLOC BAGS CONTAINING SIX USED SYRINGES BELONGING TO FINAL LOT NUMBER 9091753 WERE RECEIVED AND ALL OF THE SAMPLES EXHIBITED SIGNS OF LEAKAGE PAST STOPPER. A NUMBER OF THE SYRINGES APPEARED TO HAVE DAMAGE TO THE FLANGE AREA. NO FOREIGN MATTER WAS OBSERVED WITHIN THE FLUID PATHWAY OF THE USED SYRINGES. TWO SEALED CONVENIENCE TRAYS BELONGING TO FINAL LOT NUMBER 9091753 WERE ALSO RECEIVED FOR EVALUATION. WITHIN THE FIRST TRAY, TEN SYRINGES WERE FOUND TO HAVE FLANGE DAMAGE WITH SIGNS OF PLASTIC FOREIGN MATTER BEHIND THE STOPPER. WITHIN THE SECOND TRAY, FOUR SYRINGES WERE FOUND TO HAVE FLANGE DAMAGE WITH SIGNS OF PLASTIC FOREIGN MATTER BEHIND THE STOPPER. THIS FOREIGN MATTER WAS LIKELY A RESULT OF THE FLANGE DAMAGE. ALL OF THE UNUSED SAMPLES WERE FUNCTIONALLY TESTED AND NO SIGNS OF LEAKAGE WERE OBSERVED. THOUGH IT COULD NOT BE OBSERVED WITHIN THE RETURNED USED SAMPLES, IT IS POSSIBLE THAT THE PLASTIC FOREIGN MATTER FROM THE FLANGE DAMAGE BECAME PLACED BETWEEN THE STOPPER AND THE SYRINGE BARREL WALL, ALLOWING A CHANNEL FOR LEAKAGE IN A SMALL AMOUNT OF SYRINGES. A CORRECTIVE ACTION PLAN AND PREVENTIVE ACTION PLAN HAS BEEN OPENED FOR THIS INCIDENT TO FURTHER INVESTIGATE THE DAMAGE TO THE SYRINGE AND THE POTENTIAL IMPACTS OF THE RESULTING FOREIGN MATTER ON LEAKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED BEFORE USE WITH A SYRINGE 5ML LL TIP BULK CONVENIENCE PAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT THE SYRINGES ARE LEAKING FROM THE PLUNGER. 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." 517 OCCURRENCES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE OCCURRED BEFORE USE WITH A SYRINGE 5ML LL TIP BULK CONVENIENCE PAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT THE SYRINGES ARE LEAKING FROM THE PLUNGER. 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." 517 OCCURRENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322698 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