BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA PROTECTOR (P13-O)

    MDR report key: 16415270 · Received February 22, 2023

    Report

    Report Number
    3003152976-2023-00031
    Event Type
    Malfunction
    Date Received
    February 22, 2023
    Date of Event
    January 26, 2023
    Report Date
    March 24, 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

    H6: INVESTIGATION SUMMARY ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A BROKEN PROTECTOR PIN WAS OBSERVED. THIS LIKELY OCCURRED DUE TO THE FORCE OF CONNECTING THE PROTECTOR ONTO THE VIAL, THERE IS NO VISIBLE ISSUE TO INDICATE THE PROTECTOR COULD NOT FIT SECURELY ONTO 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.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED WHILE USING BD PHASEAL OPTIMA PROTECTOR (P13-O) BREAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PROTECTOR SKIRT FLEW OFF THE VIAL CAP AND BROKE OFF. THEY SPIKED 4 VIALS TODAY AND OUT OF 4 VIALS , 1 HAD BROKE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHASEAL OPTIMA PROTECTOR (P13-O) BREAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PROTECTOR SKIRT FLEW OFF THE VIAL CAP AND BROKE OFF. THEY SPIKED 4 VIALS TODAY AND OUT OF 4 VIALS , 1 HAD BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644133 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