BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDITECH

    MDR report key: 15112 · Received January 14, 1994

    Report

    Report Number
    15112
    Event Type
    Malfunction
    Date Received
    January 14, 1994
    Date of Event
    July 12, 1993
    Report Date
    July 16, 1993
    Manufacturer
    MEDITECH
    Product Code
    FKO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: CT GUIDED INTRA-ABDOMINAL CATHETER PLACEMENTPROBLEM: 2 CM DISTAL END OF CATHETER BROKE OFF IN PATIENT'S ABDOMINAL FASCIA DURING REPOSITIONING. CATHETER WAS VERY BRITTLE AND BROKE OFF AT SIDE HOLE. NO ABNORMAL PROCEDURE WAS DONE; CATHETER SHOULD NOT HAVE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDITECH SINGLE STEP CATHETER FKO MEDITECH 20-550 52200

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR