BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC WING

    MDR report key: 20623523 · Received November 6, 2024

    Report

    Report Number
    1710034-2024-01282
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    October 17, 2024
    Report Date
    February 4, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903826339
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDRESS UPDATED IN E TAB.

    Additional Manufacturer Narrative · 0

    A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿I WAS GIVEN 5 MORE (9 + CATHETERS FAILING TOTAL) FROM THE NWCH ED - THEY ARE ALL THE SAME LOT # 422721. I WAS ALSO TOLD ACUTE CARE AND OPERATING ROOM HAVE HAD ¿STICKY¿ ISSUES WITH NEEDLE RETRACTION. THEY HAVE NOT SAVED THEM NOR, PUT IN A SAFE CONNECT. THE NURSE MANAGER OF ACUTE SUPPLIED THESE LOT NUMBERS IN USE AT THIS TIME: WEST: 4220015, 4222721 EAST: 4123610, 4102957, 3361863, 4037545 NO PACKAGING/DEVICES WERE SAVED ON THOSE UNITS.¿ NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1991853 BD INSYTE AUTOGUARD BC WING PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4123610 00382903826339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown