BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR LUER LOCK N35C MULTIPACK

    MDR report key: 12021633 · Received June 17, 2021

    Report

    Report Number
    3003152976-2021-00332
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 19, 2021
    Report Date
    November 3, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150050
    PMA / PMN Number
    K140591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: SAMPLES AND PHOTOS RECEIVED FOR INVESTIGATION. UPON INSPECTION OF THE IMAGE AND SAMPLE RECEIVED, IT CAN BE SEEN THAT THE INJECTOR WAS CONNECTED TO A CONNECTOR AND THE SAFETY SLEEVE GRIPS HAVE BEEN PULLED OUT OF PLACE AND THE NEEDLE IS EXPOSED ; MOST LIKELY CAUSED BY MISUSE OF THE DEVICE DURING CONNECTION/DISCONNECTION OF THE PHASEAL DEVICE AGAINST THE MATING COMPONENT. THE PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING VERIFICATION OF ALL CRITICAL DIMENSIONS, SUCH AS THE SAFETY SLEEVE, WITHIN THE REQUIRED SPECIFICATIONS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2003118, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. IT IS IMPORTANT TO FOLLOW THE INSTRUCTIONS FOR USE WHEN USING PHASEAL DEVICES TO ENSURE THAT THE PRODUCT IS FUNCTIONING PROPERLY. THE INJECTOR NEEDLES ARE EXPOSED IF NOT PROPERLY DISENGAGED, WHICH ALSO LEADS TO BREAKAGE OF THE SAFETY SLEEVE. IT IS IMPORTANT TO HOLD ONTO THE WHITE PART OF THE INJECTOR BEFORE ENGAGING/DISENGAGING. DO NO TOUCH THE BLUE PART; IF GRIPS OF THE SAFETY SLEEVE ARE REMOVED FROM THEIR PLACE, THE INJECTOR IS ACTIVATED CAUSING NEEDLE EXPOSURE. THE INJECTOR MUST BE REMOVED PULLING IT BACK: IF IT IS REMOVED WITHOUT DOING THIS THE GRIPS ARE REMOVED FROM THEIR PLACE AND NEEDLE EXPOSURE HAPPENS. IF THE INJECTOR HAS BEEN FORCED WHILE ENGAGING, THE GRIPS CAN ALSO GET DAMAGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INJECTOR LUER LOCK N35C MULTIPACK NEEDLE WAS EXPOSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER ADMINISTRATION OF ADRIACIN, THE HCP DISCONNECTED THE IV SET AND FOUND THAT THE INJECTOR NEEDLE WAS EXPOSED.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT INJECTOR LUER LOCK N35C MULTIPACK NEEDLE WAS EXPOSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER ADMINISTRATION OF ADRIACIN, THE HCP DISCONNECTED THE IV SET AND FOUND THAT THE INJECTOR NEEDLE WAS EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913194 INJECTOR LUER LOCK N35C MULTIPACK INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2003118 00382905150050

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown