BEUDAMED
    FDA Adverse Event Other Summary report: N

    V-CATH, 3FR

    MDR report key: 519293 · Received April 6, 2004

    Report

    Report Number
    2925153-2004-00002
    Event Type
    Other
    Date Received
    April 6, 2004
    Date of Event
    March 24, 2004
    Manufacturer
    HDC CORP.
    Product Code
    DQO
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CATHETER BROKE DURING REMOVAL. IN 2004 A 42 CM CATHETER WAS PLACED ON A PT. FIFTEEN DAYS LATER FACILITY ATTEMPTED TO REMOVE THE CATHETER FROM PT. THEY STARTED BY USING WARM COMPRESSOR BEFORE BEGINNING THE REMOVAL. AFTER THE WARM COMPRESSOR, THEY BEGAN TO REMOVE THE CATHETER FROM THE PT. THE FIRST 28 CM OF REMOVAL WENT VERY SMOOTH. AT THIS POINT, HOWEVER, THE CATHETER WAS STUCK. THE NURSE WAITED FOR A TIME AND BEGAN TO REMOVE THE CATHETER AGAIN. THERE WAS NO INTERVENTION PRIOR TO RESTARTING THIS REMOVAL PROCESS. THE CATHETER WAS STILL NOT FREE AND BROKE (SNAPPED) WITH LITTLE FORCE APPLIED. THE SECTION REMOVED WAS 28 CM. THE NURSE PLACED A TOURNIQUET ON THE PT'S ARM TO PREVENT THE CATHETER FROM MOVING UP THE ARM. THE PT WAS TAKEN TO SURGERY TO HAVE A "CUT DOWN" PROCEDURE PERFORMED TO REMOVE THE REMAINING OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH, 3FR PICC, VASCULAR ACCESS DEVICE DQO HDC CORP. UNK 1004

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention