BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN NECK COIL-CATH

    MDR report key: 148454 · Received January 9, 1998

    Report

    Report Number
    148454
    Event Type
    Malfunction
    Date Received
    January 9, 1998
    Date of Event
    November 28, 1997
    Report Date
    December 1, 1997
    Manufacturer
    ACCURATE SURGICAL INSTRUMENTS CORP.
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN PT AWAKENED ON 11/28/97, BED WAS WET FROM LEAKING DIALYSIS CATHETER. PT CONTACTED DIALYSIS CENTER AND ADVISED TO COME IN. AFTER ARRIVAL, WHILE CATHETER BEING CLEANED FOR APPLICATION OF NEW CONNECTOR, APPROX 5MM OF CATHETER BROKE OFF. UPON FURTHER INSPECTION A CRACK WAS DISCOVERED. CATHETER WAS CUT OFF TO PREVENT FURTHER LEAKAGE AND/OR CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN NECK COIL-CATH Implant PERITONEAL DIALYSIS CATHETER FJS ACCURATE SURGICAL INSTRUMENTS CORP. * HA24-N30-40-40-4/97

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other