BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PROTECTOR P50

    MDR report key: 9662093 · Received February 3, 2020

    Report

    Report Number
    3003152976-2020-00033
    Event Type
    Malfunction
    Date Received
    February 3, 2020
    Date of Event
    January 13, 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

    H.6. INVESTIGATION: ONE PHOTO SAMPLE AND TWO UNUSED PROTECTOR SAMPLES WERE 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 SAMPLES WERE EVALUATED, NO ISSUES WERE IDENTIFIED DURING THE VISUAL INSPECTION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 1909138, 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. 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 HAS BEEN REPORTED THAT THE BD¿ PROTECTOR P50 HAS BEEN FOUND EXPERIENCING CORING DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: RUBBER HAS FALLEN DURING THE ATTACHMENT OF AN UNDILUTED GEMKO DRUG. THEY MEAN WITH ¿RUBBER¿ AS A TOP OF THE VIAL. GEMKO 1000MG / KOÇAK FARMA / LOT: 1964932. PER REP: THAT PROTECTOR IS ASSEMBLED ONTO THE VIAL MANUALLY.

    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 CORING DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: RUBBER HAS FALLEN DURING THE ATTACHMENT OF AN UNDILUTED GEMKO DRUG. THEY MEAN WITH ¿RUBBER¿ AS A TOP OF THE VIAL. GEMKO 1000 MG / KOÇAK FARMA / LOT: 1964932. PER REP: THAT PROTECTOR IS ASSEMBLED ONTO THE VIAL MANUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126120 BD PROTECTOR P50 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515105 1909138 30382905151058

    Patients

    Seq Age Sex Outcome Treatment
    1 Other