BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWAN NECK COIL-CATH

    MDR report key: 148461 · Received January 9, 1998

    Report

    Report Number
    148461
    Event Type
    Injury
    Date Received
    January 9, 1998
    Date of Event
    November 12, 1997
    Report Date
    November 14, 1997
    Manufacturer
    ACCURATE SURGICAL INSTRUMENT CORP.
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TENCKHOFF CATHETER PLACED 11/4/97. 11/5/97 PT C/O SEVERE ABDOMINAL PAIN. CULTURES REMAINED NEGATIVE FOR 6 DAYS BUT DIALYSATE CLEARED WITH ADDITION OF ANTIBIOTIC. 11/6/97 PERITONEAL CATHETER LEAKING WITH SEVERAL AREAS THAT APPEARED AS CUTS. APPLICATION OF DAVRON CLAMP CAUSED CATHETER TO CRIMP. 11/12/97 CATHETER EMERGENTLY REMOVED AND REPLACED DUE TO CONTINUED LEAKING WITH CLAMP IN PLACE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention