BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTOR P21

    MDR report key: 11918100 · Received June 1, 2021

    Report

    Report Number
    3003152976-2021-00307
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 4, 2021
    Report Date
    July 12, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905151026
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A FOREIGN PARTICLE WAS OBSERVED INSIDE THE VIAL. WHILE THE PARTICLES APPEAR TO BE CONSISTENT WITH THE RUBBER STOPPER OF THE VIAL, WITHOUT THE PHYSICAL SAMPLE TO EVALUATE, WE CANNOT CONFIRM THE ORIGIN. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2011110, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THESE ISSUES. FRAGMENTATION TESTING IS PERFORMED ACCORDING TO PROCEDURE, TO EVALUATE ANY PARTICULATES GENERATED BY THE INJECTOR WHEN MATED TO OTHER COMPONENTS AFTER TEN ACTIVATIONS. TESTING WAS REVIEWED FOR LOT 2011110 AND RESULTS WERE FOUND TO BE ACCEPTABLE. FOUR RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. FRAGMENTATION TESTING WAS PERFORMED USING THE RETAINED PROTECTORS AND SAMPLE INJECTORS, IN ALL CASES THE PRODUCT MET REQUIRED SPECIFICATIONS. BASED ON THE AVAILABLE WE ARE NOT ABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PROTECTOR P21 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS MANUALLY PLACED ON A VIAL OF KADCYLA. THIS VIAL CONTAINS TRASTUZUMAB-EMTANSIN POWDER. WHILE DISSOLVING THE POWDER WITH AQUA FOR INJECTION, WE NOTICED A PARTICLE OF THE SEPTUM IN THE VIAL. CORRECT VOLUME WAS THEN WITHDRAWN VERY CAREFULLY BY SYRINGE FROM VIAL, MAKING SURE THAT PARTICLE REMAINED IN VIAL.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THAT PROTECTOR P21 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS MANUALLY PLACED ON A VIAL OF KADCYLA. THIS VIAL CONTAINS TRASTUZUMAB-EMTANSIN POWDER. WHILE DISSOLVING THE POWDER WITH AQUA FOR INJECTION, WE NOTICED A PARTICLE OF THE SEPTUM IN THE VIAL. CORRECT VOLUME WAS THEN WITHDRAWN VERY CAREFULLY BY SYRINGE FROM VIAL, MAKING SURE THAT PARTICLE REMAINED IN VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811950 PROTECTOR P21 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2011110 00382905151026

    Patients

    Seq Age Sex Outcome Treatment
    1