BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTOR P50 MULTIPACK

    MDR report key: 10348370 · Received July 30, 2020

    Report

    Report Number
    3003152976-2020-00332
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    July 8, 2020
    Report Date
    September 14, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    50382905151069
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 7/16/2020. H.6. INVESTIGATION: TWO PROTECTORS ATTACHED TO TWO VIALS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE OBSERVED ON THE PROTECTORS, THE NEEDLE ON THE PROTECTOR PENETRATED THE VIAL STOPPER PROPERLY, HOWEVER IT WAS NOTED THE PLASTIC COVER FROM THE VIAL WAS NOT REMOVED BEFORE CONNECTING THE PROTECTOR TO THE VIAL. DURING OUR EVALUATION, A FOREIGN PARTICLE WAS OBSERVED INSIDE THE VIAL. AFTER FURTHER EVALUATION WE FOUND THE PARTICLE WAS CONSISTENT WITH MATERIAL FROM THE RUBBER STOPPER OF THE VIAL. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2001112, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. FRAGMENTATION TESTING IS PERFORMED ACCORDING TO PROCEDURE, TO EVALUATE ANY PARTICULATES GENERATED AFTER TEN ACTIVATIONS. FRAGMENTATION TESTING WAS REVIEWED FOR THE REPORTED LOT AND RESULTS WERE FOUND TO BE ACCEPTABLE. WHILE PHASEAL NEEDLES ARE DESIGNED TO REDUCE CORING, THERE ARE SEVERAL FACTORS THAT MAY IMPACT CORING TENDENCY. CORING FROM THE MEMBRANE MAY OCCUR DUE TO FRAGMENTATION CAUSED BY MULTIPLE INJECTIONS OR EXCESSIVE WELDING OF THE MEMBRANE. CORING OF THE RUBBER STOPPER MAY RESULT DEPENDING ON THE STOPPER QUALITY, THE DESIGN AND DIMENSIONS OF THE NEEDLES USED, OR IF A POOR CONNECTION OF THE PROTECTOR OCCURS. BASED ON THE AVAILABLE WE ARE NOT ABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROTECTOR P50 MULTIPACK EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING INSPECTION AFTER PREPARATION OF ABRAXANE, CORING WAS FOUND IN INFUSION BAGS AND 2 OF 3 VIALS.

    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 THE PROTECTOR P50 MULTIPACK EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING INSPECTION AFTER PREPARATION OF ABRAXANE, CORING WAS FOUND IN INFUSION BAGS AND 2 OF 3 VIALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812658 PROTECTOR P50 MULTIPACK INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515106 2001112 50382905151069

    Patients

    Seq Age Sex Outcome Treatment
    1 Other