BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHASEAL PROTECTOR P53

    MDR report key: 9718045 · Received February 17, 2020

    Report

    Report Number
    3003152976-2020-00062
    Event Type
    Malfunction
    Date Received
    February 17, 2020
    Date of Event
    January 15, 2020
    Report Date
    April 6, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905151072
    PMA / PMN Number
    K123213
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR PHYSICALS SAMPLES THAT DISPLAY THE REPORTED ISSUE WERE PROVIDED FOR INVESTIGATION. A DEVICE HISTORY WAS PERFORMED AND FOUND NO NO-CONFORMANCES RELATED TO THE REPORTED ISSUE DURING PRODUCTION OF LOTS 1704010 AND 1910111. FOUR RETAINED SAMPLES OF EACH LOT WERE USED FOR ADDITIONAL EVALUATION. TWO SAMPLES OF LOT 1704010 AND TWO OF LOT 1910111WERE CONNECTED TO A STANDARD 32MM VIAL USING THE M12 ASSEMBLY FIXTURE, IN ALL INSTANCES THE PROTECTORS PROPERLY FIT THE VIAL AND NO LEAKAGE WAS OBSERVED. THE ADDITIONAL TWO SAMPLES OF EACH LOT WHERE THEN CONNECTED TO A VIAL OF PIPERACILLIN/TAZOBACTAM USING THE M12 ASSEMBLY FIXTURE. IN ALL SAMPLES IT WAS NOTED THAT THE PROTECTOR WAS NOT TO SECURELY FIT ONTO THE VIAL AND A LEAKAGE BETWEEN THE PROTECTOR AND VIAL WAS OBSERVED. PRODUCT IS VISUALLY AND FUNCTIONALLY TESTED THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING LEAKAGE TESTING. TEST RESULTS WERE REVIEWED FOR THE REPORTED LOTS, ALL PRODUCT MET REQUIRED SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. IT WOULD APPEAR THE FAILURE IS RELATED TO THE CAP FROM THE VIAL THAT WAS USED WHICH DID NOT ALLOW FOR A SECURE CONNECTION BETWEEN THE VIAL AND PROTECTOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PHASEAL PROTECTOR P53 IS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHASEAL PROTECTOR IS LEAKING WHEN THEY USING IT ON PIP/TAZ WITH A THICK VIAL.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181924 PHASEAL PROTECTOR P53 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515107 1704010 30382905151072

    Patients

    Seq Age Sex Outcome Treatment
    1 Other