BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ OPTIMA PROTECTOR (P13-O)

    MDR report key: 16375220 · Received February 14, 2023

    Report

    Report Number
    3003152976-2023-00024
    Event Type
    Malfunction
    Date Received
    February 14, 2023
    Date of Event
    January 24, 2023
    Report Date
    March 8, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150609
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE SPIKE APPEARS TO BE SLIGHTLY CROOKED, ALTHOUGH IT CANNOT BE FULLY VERIFIED AS THE PHOTO IS BLURRY. THERE IS NO VISIBLE DEFECTS OBSERVED WITHIN THE PHOTO THAT COULD INDICATE WHY THE PROTECTOR WOULD NOT INSERT INTO THE VIAL. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2201414, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED AND NO DAMAGE OR DEFECTS WERE OBSERVED. FUNCTIONAL TESTING WAS PERFORMED, CONNECTING THE PROTECTOR SAMPLE TO A VIAL, INJECTOR, AND SYRINGE PER THE INSTRUCTIONS FOR USE PROVIDED WITH THE PRODUCT. IN ALL CASES THE PROTECTOR WAS PROPERLY FITTED TO THE VIAL, LIQUID WAS ABLE TO BE DRAWN FROM THE VIAL, AND THE PRODUCT FUNCTIONED AS INTENDED. PRODUCT IS VISUALLY AND FUNCTIONALLY TESTED THROUGHOUT MANUFACTURING ACCORDING TO PROCEDURE, ENSURING THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING VERIFICATION THAT ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION, NO ISSUES RELATED TO THE REPORTED ISSUE WERE NOTED. BASED ON OUR INVESTIGATION WE CANNOT IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPIKE OF THE BD PHASEAL¿ OPTIMA PROTECTOR (P13-O) WAS BENT AND LOOSE, AND THE RUBBER COVER OF THE VIAL SPIKE WAS ALSO DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PLASTIC SPIKE IS BENT AND LOSE AND THE RUBBER COVER OF THE VIAL SPIKE IS SQUISHED UP. THEY USED THE M12-O ASSEMBLY FIXTURE, IT IS BRAND NEW. THE MEDICATION THAT THEY WERE TRYING TO SPIKE WAS TAXIL IV - SANDOZ BRAND 5ML VIAL SIZE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPIKE OF THE BD PHASEAL¿ OPTIMA PROTECTOR (P13-O) WAS BENT AND LOOSE, AND THE RUBBER COVER OF THE VIAL SPIKE WAS ALSO DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PLASTIC SPIKE IS BENT AND LOSE AND THE RUBBER COVER OF THE VIAL SPIKE IS SQUISHED UP. THEY USED THE M12-O ASSEMBLY FIXTURE, IT IS BRAND NEW. THE MEDICATION THAT THEY WERE TRYING TO SPIKE WAS TAXIL IV - SANDOZ BRAND 5ML VIAL SIZE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655054 BD PHASEAL¿ OPTIMA PROTECTOR (P13-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515060 2201414 00382905150609

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown