BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    51 IBP

    MDR report key: 36542 · Received July 3, 1996

    Report

    Report Number
    36542
    Event Type
    Malfunction
    Date Received
    July 3, 1996
    Date of Event
    February 5, 1996
    Report Date
    February 8, 1996
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Product Code
    LFJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HUB ON ARTERIAL SIDE OF LONG TERM HEMODIALYSIS BROKE OFF (NOT RETAINED) AND COULD NOT BE REPAIRED. PT REQUIRED SURGICAL REMOVAL OF BROKEN CATHETER AND PLACEMENT OF NEW ONE. PT TOLERATED PROCEDURE WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 51 IBP Implant PEDIATRIC HEMODIALYSIS CATHETER LFJ MEDICAL COMPONENTS, INC. * M502740

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other