BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOCATH-T 22-G

    MDR report key: 249090 · Received November 8, 1999

    Report

    Report Number
    6000097-1999-00013
    Event Type
    Injury
    Date Received
    November 8, 1999
    Date of Event
    September 28, 1999
    Report Date
    October 11, 1999
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    FOZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CATHETER DISCONNECTION FROM IV HUB REPORTED. REPORT RECEIVED FROM ABBOTT INTERNATIONAL AFFILIATE, ABBOTT SPAIN STATES: "AN ABBOCATH WAS PLACED IN A MALE IN ORDER TO START CONTINUOUS IV FLUID THERAPY. TWELVE HOURS AFTER THE DEVICE WAS PLACED, THE SYSTEM FOR CONTINUOUS IV THERAPY WAS DISCONNECTED, AND AN ADAPTER WITH HEPARIN WAS CONNECTED TO THE ABBOCATH. AFTER THAT, THE NURSE REALIZED THAT THE DRESSING AROUND THE ABBOCATH-T WAS DAMP. THE NURSE TOOK AWAY THE DRESSING AND REALIZED THAT THE CATHETER OF THE ABBOCATH HAD DETACHED FROM THE DEVICE. A SURGEON EXTRACTED THE DEVICE FROM THE FOREARM. THE PT DID NOT PRESENT ANY UNTOWARD CONSEQUENCE." NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOCATH-T 22-G CANNULA FOZ ABBOTT LABORATORIES, INC. NA 53-364-VM

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention IV.| PT WAS RECEIVING URBASON OF AN UNSPECIFIED AMOUNT