BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTOR P15J

    MDR report key: 12602149 · Received October 9, 2021

    Report

    Report Number
    3003152976-2021-00677
    Event Type
    Malfunction
    Date Received
    October 9, 2021
    Date of Event
    September 8, 2021
    Report Date
    October 15, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLE OR PHOTOS WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2003114, NO DEVIATIONS OR NON-CONFORMITIES 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. THE TEST RESULTS FOR THE REPORTED BATCH WERE REVIEWED AND THE RESULTS WERE FOUND TO BE ACCEPTABLE. FOUR RETAINED SAMPLES FROM LOT 2003114 WERE USED FOR FURTHER EVALUATION. TEST WAS PERFORMED, PENETRATING THE SHIELD WITH A SAMPLE INJECTOR TEN TIMES. IN ALL CASES, THE PRODUCT WORKED AS INTENDED AND NO NUCLEI WERE IDENTIFIED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THREE PROTECTOR P15J SHOWED SIGNS OF CORING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "DURING PREPARATION OF KEYTRUDA BY ATTACHING THE PROTECTOR TO THE VIAL USING AF, A RUBBER-LIKE FLOATING SUBSTANCE WAS FOUND IN THE INFUSION BAG."

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO SAMPLE OR PHOTOS WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE PROVIDED LOT NUMBER, NO DEVIATIONS OR NON-CONFORMITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THESE ISSUES. FOUR RETAINED SAMPLES FROM THE PROVIDED LOT WERE USED FOR FURTHER EVALUATION. IN ALL CASES, THE PRODUCT WORKED AS INTENDED AND NO NUCLEI WERE 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. IT IS IMPORTANT TO ENSURE THE VIAL IS NOT EXPIRED AS THAT CAN IMPACT THE QUALITY OF THE RUBBER STOPPER. BASED ON AVAILABLE INFORMATION, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED BY THIS DEVICE AND THE REPORTED ISSUE WILL CONTINUE TO BE TRACKED AND TRENDING TO OCCUR IN THE FUTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THREE PROTECTOR P15J SHOWED SIGNS OF CORING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) "DURING PREPARATION OF KEYTRUDA BY ATTACHING THE PROTECTOR TO THE VIAL USING AF, A RUBBER-LIKE FLOATING SUBSTANCE WAS FOUND IN THE INFUSION BAG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1499724 PROTECTOR P15J PROTECTOR ONB BECTON DICKINSON, S.A. 2003114

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown