BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR LUER LOCK N35C MULTIPACK

    MDR report key: 12145635 · Received July 9, 2021

    Report

    Report Number
    3003152976-2021-00379
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    June 11, 2021
    Report Date
    September 29, 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

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 8/25/2021. H.6. INVESTIGATION: PHOTOS AND ONE SAMPLE HAVE BEEN RECEIVED FOR INVESTIGATION, UPON OBSERVATION CLAIMED INJECTOR WAS LUER CONNECTED TO A CONNECTOR THE GRIPS FROM THE SAFETY SLEEVE ARE REMOVED FROM THEIR PLACE; MOST PROBABLY CAUSED BY A MISUSE OF THE DEVICE BY THE USER DURING THE CONNECTION/DISCONNECTION OF THE PHASEAL DEVICE AGAINST THE MATTING COMPONENT. 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. MOREOVER, FIVE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION, NO DAMAGE OR OTHER DEFECTS WAS OBSERVED ON ANY OF THE PRODUCT. FUNCTIONAL TESTING WAS PERFORMED, SAMPLE WAS ATTACHED TO A SYRINGE+ A PROTECTOR CONNECTED TO A VIAL. AFTER ASPIRATING THE COLORANT FROM THE VIAL TO THE SYRINGE, NO ISSUES WERE FOUND ON THE INJECTOR. THIS PROCEDURE WAS REPEATED 3 TIMES ON EACH RETAINED SAMPLE AND NO ISSUES WERE OBSERVED DURING ALL CONNECTIONS PERFORMED ON ALL OF THEM. NO BROKEN SAFETY SLEEVE FROM THE INJECTOR WAS OBSERVED. IN ALL CASES THE PRODUCT FUNCTIONED PROPERLY, AND NO ISSUES WERE OBSERVED. TESTING RESULTS WERE REVIEWED FOR THE REPORTED LOT AND FOUND ALL PRODUCT MET REQUIRED SPECIFICATIONS. THE BREAKAGE OF THE SAFETY SLEEVE OCCURS WHEN THE INJECTOR IS NOT PROPERLY DISENGAGED. 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. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    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: THIS IS A REPORT ABOUT EXPOSED NEEDLE OF INJECTOR. ACCORDING TO THE CUSTOMER'S REPORT, WHEN THE HCP DISCONNECTED THE INJECTOR AFTER INFUSION OF ADRIACIN, ITS 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: THIS IS A REPORT ABOUT EXPOSED NEEDLE OF INJECTOR. ACCORDING TO THE CUSTOMER'S REPORT, WHEN THE HCP DISCONNECTED THE INJECTOR AFTER INFUSION OF ADRIACIN, ITS NEEDLE WAS EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040526 INJECTOR LUER LOCK N35C MULTIPACK INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2003118 00382905150050

    Patients

    Seq Age Sex Outcome Treatment
    1