BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCATH

    MDR report key: 33325 · Received June 5, 1996

    Report

    Report Number
    MW1009229
    Event Type
    Malfunction
    Date Received
    June 5, 1996
    Date of Event
    May 9, 1996
    Report Date
    May 10, 1996
    Manufacturer
    HDC CORP.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EXTREME DIFFICULTY REMOVING PICC GUIDE WIRE. PICC INSERTED RIGHT MEDIAL CEPHALIC VEIN TO SVC. UNABLE TO REMOVE GUIDE WIRE. PT SENT TO X-RAY WITH WIRE IN PLACE. REMOVED 1 1/2 HRS LATER WITH HELP. WHITE GRIP AT END OF WIRE ALSO SLIPPED OFF DURING EFFORT. THIS REPORT REPRESENTS TWO PROBLEMS ENCOUNTERED WITH THIS DEVICE (GUIDE WIRE DIFFICULTY, HUB SLIPPING OFF). ADDITIONALLY, THIS OCCURRENCE IS ONE OF SEVERAL SIMILAR PROBLEMS HOSP HAS EXPERIENCED WITH THIS CO'S PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VCATH Implant PICC LINE DQO HDC CORP. 395-060 1028

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR