BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PROTECTOR P50

    MDR report key: 9588561 · Received January 14, 2020

    Report

    Report Number
    3003152976-2019-00917
    Event Type
    Malfunction
    Date Received
    January 14, 2020
    Date of Event
    December 19, 2019
    Report Date
    March 30, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905151058
    PMA / PMN Number
    K123213
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY ONE PHOTO SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUALLY INSPECTING THE PHOTO, A GREY PARTICLE WHICH APPEARS TO BE CONSISTENT WITH THE RUBBER STOPPER IS VISIBLE INSIDE THE VIAL. WITHOUT THE ACTUAL SAMPLE TO EVALUATE, WE CANNOT VERIFY THE ORIGIN OF THE PARTICLE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 1905122, NO DEVIATIONS OR NON-CONFORMANCE'S WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THESE ISSUES. FRAGMENTATION TESTING IS PERFORMED DURING MANUFACTURING TO EVALUATE ANY PARTICULATES GENERATED AFTER TEN ACTIVATIONS. TESTING RESULTS WERE REVIEWED FOR THE REPORTED LOT AND RESULTS WERE FOUND TO BE ACCEPTABLE. FOUR RETAINED SAMPLES OF LOT 1905122 WERE USED FOR ADDITIONAL EVALUATION. FUNCTIONAL TESTING WAS ALSO PERFORMED, PENETRATING THE PROTECTOR WITH A SAMPLE INJECTOR TEN TIMES. IN ALL CASES THE PRODUCT FUNCTIONED AS INTENDED AND NO CORING WAS IDENTIFIED. 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 QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD¿ PROTECTOR P50 HAS BEEN FOUND EXPERIENCING THREE OCCURRENCES OF CONTAINING FOREIGN MATTER DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: A PIECE OF VIAL RUBBER FALLING INTO THE VIAL WHEN THE PROTECTOR IS INSERTED INTO THE VIAL.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT HAS BEEN REPORTED THAT THE BD¿ PROTECTOR P50 HAS BEEN FOUND EXPERIENCING THREE OCCURRENCES OF CONTAINING FOREIGN MATTER DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: A PIECE OF VIAL RUBBER FALLING INTO THE VIAL WHEN THE PROTECTOR IS INSERTED INTO THE VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52223 BD PROTECTOR P50 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515105 1905122 30382905151058

    Patients

    Seq Age Sex Outcome Treatment
    1 Other