BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8FR OPTICATH CATHETER

    MDR report key: 3049579 · Received March 13, 2013

    Report

    Report Number
    2025816-2013-00019
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    October 23, 2013
    Report Date
    January 28, 2013
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A TWO YEAR REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST NUMBER/SIMILAR ISSUE DID NOT IDENTIFY ANY ADDITIONAL REPORTS OR INVESTIGATIONS IDENTIFYING A MFR DEFECT/NON-CONFORMANCE. EXACT CAUSE OF THE REPORTED INCIDENT IS UNK.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING CATHETER POSITIONING/PLACEMENT PROBLEMS WITH ONE (1) 50328-06 8FR OPTICATH. IT WAS REPORTED THAT THE 50328-06 OPTICATH WAS PRE-TESTED AND SUCCESSFULLY INSERTED/FLOATED AND AFTER AN UNSPECIFIED PERIOD OF TIME, ATTENDING CLINICIAN FOUND THAT THE "CATHETER WAS KNOTTED." IT WAS ALSO REPORTED THAT THE "KNOTTED CATHETER NEEDED TO BE SURGICALLY REMOVED... THE PT IS RECOVERING WELL. THE CATHETER HAS BEEN SENT TO THE FACILITY RISK MANAGER." THE INVOLVED 52509-13 DEVICE WAS NOT RETURNED TO THE MFR FOR ANALYSIS AND INVESTIGATION. ALTHOUGH REQUESTED, ADDITIONAL RELEVANT PT, USAGE INFORMATION AS OF THE DATE OF THIS REPORT HAS NOT BEEN RECEIVED BY THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106257 8FR OPTICATH CATHETER PA CATHETER DYG ICU MEDICAL, INC. 50328-06 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1