BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA PROTECTOR

    MDR report key: 16592721 · Received March 22, 2023

    Report

    Report Number
    3003152976-2023-00090
    Event Type
    Malfunction
    Date Received
    March 22, 2023
    Date of Event
    March 2, 2023
    Report Date
    May 16, 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, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS RECEIVED FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2202401, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THREE RETAINED SAMPLES FROM THE SAME LOT WERE USED FOR FURTHER EVALUATION. THE PROTECTORS WERE SUCCESSFULLY CONNECTED TO THE VIALS, ENSURING THAT THEY FITTED CORRECTLY. THE PRODUCT WAS EVALUATED, AND NO DAMAGE OR DEFECTS WERE OBSERVED. FUNCTIONAL TESTS WERE PERFORMED ON THE SAMPLES AND NO LEAKAGE WAS IDENTIFIED BETWEEN THE PROTECTOR AND THE VIAL. THE PRODUCT UNDERGOES VISUAL AND FUNCTIONAL TESTING THROUGHOUT MANUFACTURING, INCLUDING LEAK TESTING. BASED ON THE AVAILABLE INFORMATION, WE ARE UNABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE 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 THE RUBBER DISLODGED INTO THE VIAL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VIAL WHERE THE ADAPTER PUSHED IN THE STOPPER A LITTLE BIT AND THEY WERE NOT ABLE TO PUT DILUENT INTO THE VIAL. USING P13-O.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHASEAL OPTIMA PROTECTOR THE RUBBER DISLOGED INTO THE VIAL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VIAL WHERE THE ADAPTER PUSHED IN THE STOPPER A LITTLE BIT AND THEY WERE NOT ABLE TO PUT DILUENT INTO THE VIAL. USING P13-O.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495362 BD PHASEAL OPTIMA PROTECTOR INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515060 2202401 00382905150609

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown