BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL PROTECTOR P50

    MDR report key: 9688158 · Received February 10, 2020

    Report

    Report Number
    3003152976-2020-00046
    Event Type
    Malfunction
    Date Received
    February 10, 2020
    Date of Event
    January 17, 2020
    Report Date
    March 26, 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

    INVESTIGATION: MULTIPLE PHOTOS AND TWO UNUSED PROTECTOR SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUALLY INSPECTING THE PHOTOS, A GREY PARTICLE WHICH APPEARS TO BE PART OF THE RUBBER STOPPER IS OBSERVED INSIDE THE VIAL. WITHOUT THE ACTUAL SAMPLE TO EVALUATE, WE CANNOT VERIFY THE ORIGIN OF THE PARTICLE. THE UNUSED SAMPLES WERE EVALUATED, NO ISSUES WERE IDENTIFIED DURING THE VISUAL INSPECTION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 1909138, 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. TWO ADDITIONAL RETAINED SAMPLES ALONG WITH THE TWO UNUSED PROTECTORS RETURNED OF LOT 1909138 WERE USED FOR ADDITIONAL EVALUATION. FUNCTIONAL TESTING WAS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED IT WAS REPORTED BD PHASEAL PROTECTOR P50 STOPPER DETACHED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM TURKISH TO ENGLISH: VERBATIM: ¿RUBBER HAS FALLEN DURING THE ATTACHMENT OF AN UNDILUTED KYPROLIS DRUG. THE DILUTION AND PREPARATION OF THE DRUG WAS COMPULSORY KYPROLIS 60MG / AMGEN / LOT: 1104951¿.

    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 WAS REPORTED IT WAS REPORTED BD PHASEAL PROTECTOR P50 STOPPER DETACHED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: VERBATIM: ¿RUBBER HAS FALLEN DURING THE ATTACHMENT OF AN UNDILUTED KYPROLIS DRUG. THE DILUTION AND PREPARATION OF THE DRUG WAS COMPULSORY. KYPROLIS 60 MG / AMGEN / LOT: 1104951¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154268 BD PHASEAL PROTECTOR P50 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515105 1909138 30382905151058

    Patients

    Seq Age Sex Outcome Treatment
    1 Other