BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    242403-24 2MM 7MM ATRIAL 6F MOD

    MDR report key: 303648 · Received November 2, 2000

    Report

    Report Number
    1313046-2000-00010
    Event Type
    Malfunction
    Date Received
    November 2, 2000
    Date of Event
    September 21, 2000
    Report Date
    October 19, 2000
    Manufacturer
    C.R. BARD, INC. (GLEN FALLS)
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CS INSERTION WAS MADE WITH THIS CATHETER. AFTER LESS THAN 10 MINS. OF USE INSIDE THE BODY THE OPERATOR TRIED TO ROTATE THE TIP, BUT THIS WAS IMPOSSIBLE. X-RAY REVEALED A SEVERE KINK IN THE MID-DISTAL SECTION OF THE CATHETER. THE RESULT WAS THAT THE CATHETER GOT COMPLETELY STUCK IN VESSEL AND ONLY AFTER MANY ATTEMPTS THE OPERATOR MANAGED TO WITHDRAW IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 242403-24 2MM 7MM ATRIAL 6F MOD 121030036-ORBITER DRF C.R. BARD, INC. (GLEN FALLS) * 07BK1971

    Patients

    Seq Age Sex Outcome Treatment
    1 *