BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANHUKAR CATHETER

    MDR report key: 4231899 · Received October 31, 2014

    Report

    Report Number
    MW5038973
    Event Type
    Malfunction
    Date Received
    October 31, 2014
    Date of Event
    October 28, 2014
    Report Date
    October 31, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NURSE PRACTITIONER WAS ATTEMPTING TO PLACE A CENTRAL LINE IN THE ICU PATIENT. THE GUIDEWIRE IN THE CATHETER KINKED. THE PRACTITIONER WAS UNABLE TO THREAD THE CATHETER. HE MONITORED THE PATIENT FOR HEMATOMA AND BLEEDING. THE CATHETER PLACEMENT WAS NOT COMPLETED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698479 MANHUKAR CATHETER MANHUKAR CATHETER MPB COVIDIEN REF 8888135247 324802X

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR