BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-TRACE IUPC INTRAUTERINE PRESSURE CATHETER

    MDR report key: 2266951 · Received September 19, 2011

    Report

    Report Number
    2266951
    Event Type
    Malfunction
    Date Received
    September 19, 2011
    Date of Event
    September 7, 2011
    Report Date
    September 19, 2011
    Manufacturer
    KENDALL
    Product Code
    KXO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INTRAUTERINE PRESSURE CATHETER WITH SIMULTANEOUS AMNIOINFUSION CAPABILITY DID NOT REGISTER ANY PRESSURE. CATHETER ADJUSTED AND CABLE CHANGED WITH NO IMPROVEMENT. CATHETER REMOVED AND NEW IUPC INSERTED WITH ADEQUATE READINGS. DEFECTIVE CATHETER TIP WITH SENSOR WAS INSPECTED BY PHYSICIAN. PHYSICIAN APPLIED PRESSURE TO SENSOR TIP AND DID NOT GET PRESSURE READING ON MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-TRACE IUPC INTRAUTERINE PRESSURE CATHETER INTRAUTERINE PRESSURE CATHETER KXO KENDALL * 112900

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR NO OTHER THERAPIES