BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE CHEMOSITE

    MDR report key: 117439 · Received August 29, 1997

    Report

    Report Number
    1219930-1997-01932
    Event Type
    Malfunction
    Date Received
    August 29, 1997
    Date of Event
    July 14, 1997
    Report Date
    August 1, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    09/04/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA. IT HAS COME TO THE MFRS ATTENTION THAT THE INTRODUCER SPLIT BUT, THE CATHETER DID NOT BREAK. THEREFORE, PLEASE DISREGARD THIS MFR REPORT # (1210030-1997-01932) AS THE EVENT WAS NOT REPORTABLE UNDER DEPARTMENTAL GUIDELINES.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A PORT INFUSION PROCEDURE. REPORTEDLY, THE CATHETER BROKE. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE CHEMOSITE IMPLANTABLE VENOUS ACCESS SYSTEM LJT UNITED STATES SURGICAL CORP. NA N7A03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN