BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL PROTECTOR P50

    MDR report key: 9589874 · Received January 15, 2020

    Report

    Report Number
    3003152976-2019-00916
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    November 28, 2019
    Report Date
    March 23, 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 AND ONE UNUSED PROTECTOR SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUALLY INSPECTING THE PHOTO, A GREY PARTICLE INSIDE THE VIAL CAN BE OBSERVED. WITHOUT THE ACTUAL SAMPLE TO EVALUATE, WE CANNOT VERIFY THE ORIGIN OF THE PARTICLE. THE UNUSED SAMPLE WAS EVALUATED, NO ISSUES WERE IDENTIFIED AND NO PARTICLES WERE OBSERVED AFTER FUNCTIONAL TESTING. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 1905122, NO DEVIATIONS OR NON-CONFORMANCES 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 WAS REPORTED THAT A PIECE OF THE RUBBER FELL INTO VIAL WHEN PROTECTOR WAS INSERTED WITH A BD PHASEAL¿ PROTECTOR P50. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (3 OF 4 COMPLAINTS) A PIECE OF VIAL RUBBER FALLING INTO THE VIAL WHEN THE PROTECTOR IS INSERTED INTO THE VIAL.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. 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 A PIECE OF THE RUBBER FELL INTO VIAL WHEN PROTECTOR WAS INSERTED WITH A BD PHASEAL¿ PROTECTOR P50. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (3 OF 4 COMPLAINTS) 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
    57333 BD PHASEAL PROTECTOR P50 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515105 1905122 30382905151058

    Patients

    Seq Age Sex Outcome Treatment
    1 Other