BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUCATH, ACE 18GX2.25

    MDR report key: 9199606 · Received October 16, 2019

    Report

    Report Number
    3006260740-2019-03060
    Event Type
    Malfunction
    Date Received
    October 16, 2019
    Report Date
    October 16, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    FOZ
    UDI-DI
    00801741137945
    PMA / PMN Number
    K162894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY A NURSE AT THE FACILITY, "BRACHIAL VEIN JUST ABOVE AC. SHE WAS A VERY DIFFICULT PATIENT. MAYBE A LITTLE OVER 1CM DEEP, IT WAS DIFFICULT TO VISUALIZE MY TIP BUT WHEN I THOUGHT I WAS IN I TRIED ADVANCING THE WIRE AND I MET RESISTANCE AT THE HALFWAY POINT SO I TRIED PULLING/SLIDING THE GUIDE WIRE BACK AND COULDN¿T. I TRIED REMOVING THE WHOLE DEVICE AND MET RESISTANCE JUST UNDER THE SKIN WHEN THE WHOLE UNIT WAS ALMOST OUT. I PANICKED AND TRIED RETRACTING AND THE CATHETER CAME OUT BUT THE COILED TIP STAYED. I APPLIED HEAT FOR SEVERAL MINUTES AND GAVE A GENTLE TUG AND IT CAME OUT. THE TIP WAS STILL COILED SO I WAS CONFIDENT NOTHING HAD BROKEN OFF. " IT WAS FURTHER STATED THAT, "IT CAME OUT AND THE TIP LOOKED INTACT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993591 ACCUCATH, ACE 18GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BARD ACCESS SYSTEMS N/A UNK 00801741137945

    Patients

    Seq Age Sex Outcome Treatment
    1