BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR P14

    MDR report key: 15118022 · Received July 27, 2022

    Report

    Report Number
    3003152976-2022-00335
    Event Type
    Malfunction
    Date Received
    July 27, 2022
    Date of Event
    June 24, 2022
    Report Date
    September 27, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905151002
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2201139, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. FIVE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR DEFECTS WERE OBSERVED. FUNCTIONAL TESTING WAS PERFORMED, CONNECTING THE PROTECTORS TO A VIAL USING THE M12 ASSEMBLY FIXTURE, THEN TO AN INJECTOR AND SYRINGE PER THE INSTRUCTIONS FOR USE PROVIDED WITH THE PRODUCT. IN ALL CASES LIQUID WAS ABLE TO BE DRAWN FROM THE VIAL, THE EXPANSION CHAMBER PROPERLY EXPANDED, NO LEAKAGE INTO THE EXPANSION CHAMBER OR BETWEEN THE PROTECTOR AND VIAL WAS OBSERVED, AND THE PRODUCT FUNCTIONED AS INTENDED. PRODUCT UNDERGOES A SERIES OF TESTING DURING MANUFACTURING TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. THESE TESTS INCLUDE VISUAL INSPECTIONS ALONG WITH LEAKAGE TESTING, FLOW RATE, AND VERIFICATION OF THE PROPER PLACEMENT AND FUNCTION OF THE EXPANSION CHAMBER. ALL RECORDS WERE REVIEWED FOR THE REPORTED LOT AND RESULTS WERE FOUND TO BE ACCEPTABLE. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P14 EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CONTINUES TO HAVE ISSUES WITH P-14 PROTECTORS NOT OPERATING CORRECTLY. SOMETIMES CHEMO LEAKS FROM THE DEICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ PROTECTOR P14 EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CONTINUES TO HAVE ISSUES WITH P-14 PROTECTORS NOT OPERATING CORRECTLY. SOMETIMES CHEMO LEAKS FROM THE DEICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2921826 BD PHASEAL¿ PROTECTOR P14 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2201139 00382905151002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown