BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICUT CATHETER

    MDR report key: 177576 · Received July 17, 1998

    Report

    Report Number
    9611018-1998-00009
    Event Type
    Malfunction
    Date Received
    July 17, 1998
    Report Date
    June 17, 1998
    Manufacturer
    SHERWOOD MEDICAL INDUSTRIES
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE CANNULA BENDS CAUSING AN OCCLUSION IN THE ARTERY. THIS CAUSES PROBLEMS DURING USE ON BABIES WHEN THEY RUN ARTERIAL LINES. NO OTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICUT CATHETER CATHETER FOZ SHERWOOD MEDICAL INDUSTRIES NA 97I238T

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN