BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC WING

    MDR report key: 18297479 · Received December 8, 2023

    Report

    Report Number
    1710034-2023-01433
    Event Type
    Malfunction
    Date Received
    December 8, 2023
    Date of Event
    November 10, 2023
    Report Date
    March 25, 2024
    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
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 0

    H.3. 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

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿20G IV CATHETER PLASTIC CATCHING ON THE NEEDLE OR SPLIT IN HALF AND WILL NOT THREAD. ONE PATIENT WAS STUCK SIX TIMES DURING NIGHT SHIFT DUE TO THE CATHETER NOT THREADING, A DIFFERENT PATIENT WAS ALSO STUCK FIVE TIMES DURING THE DAY DUE TO THIS ISSUE. LOT 3222132¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825286 BD INSYTE AUTOG BC WING PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3222132 00382903826339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown