BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PROTECTOR P20-O MULTIPACK

    MDR report key: 15782769 · Received November 11, 2022

    Report

    Report Number
    3003152976-2022-00507
    Event Type
    Malfunction
    Date Received
    November 11, 2022
    Date of Event
    October 18, 2022
    Report Date
    February 13, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150654
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO PHYSICAL SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THREE PHOTOS WERE PROVIDED WHICH DISPLAY THE PROTECTOR AND VIAL INSIDE A PLASTIC BAG. THERE IS NO DAMAGE OR OTHER DEFECTS THAT CAN BE IDENTIFIED WITHIN THE PHOTO. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2203406, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FIVE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED AND NO DAMAGE OR DEFECTS WERE OBSERVED AND ALL DIMENSIONAL EVALUATIONS VERIFIED THE PRODUCT WAS WITHIN SPECIFICATIONS. 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

    ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, (B)(6) WAS USED AS A PLACE HOLDER. 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 PROTECTOR P20-O MULTIPACK THE RUBBER STOPPER WAS PUSHED INTO THE VIAL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PUTTING OPTIMA P20 PROTECTOR ONTO THE RITUXAN VIAL IN THE HOOD IN PHARMACY, THE RUBBER STOPPER CAVED INTO THE VIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PROTECTOR P20-O MULTIPACK THE RUBBER STOPPER WAS PUSHED INTO THE VIAL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PUTTING OPTIMA P20 PROTECTOR ONTO THE RITUXAN VIAL IN THE HOOD IN PHARMACY, THE RUBBER STOPPER CAVED INTO THE VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2879222 BD PROTECTOR P20-O MULTIPACK INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515065 2203406 00382905150654

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown