BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURFLO IV CATHETER

    MDR report key: 5112599 · Received September 30, 2015

    Report

    Report Number
    5112599
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Date of Event
    September 10, 2015
    Report Date
    September 16, 2015
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PATIENT HAD AN EXTERNAL JUGULAR 18 GAUGE SURFLO IV 2 INCH CATHETER PLACED EARLIER THIS MONTH. A COUPLE OF DAYS LATER, A NURSE NOTED THE DRESSING TO BE MOIST AND LEAKING AS SHE TRIED TO FLUSH THE CATHETER. THE DRESSING WAS REMOVED. THE EJ CANNULA WAS NOTED TO BE DETACHED FROM THE HUB AND THE CANNULA WAS NOT VISIBLE AT THE SKIN SURFACE. THE PATIENT'S NECK WAS PALPATED AND THE CATHETER/CANNULA COULD BE FELT UNDER THE SKIN SURFACE. A SOFT TISSUE X-RAY REVEALED APPROXIMATELY A 4 CM CATHETER/CANNULA FRAGMENT IN THE SOFT TISSUES OF THE NECK. THE PATIENT WAS TAKEN TO SURGERY FOR REMOVAL OF THE RETAINED DISTAL PORTION OF THE ANGIOCATH. THE ANESTHESIOLOGISTS SAID THAT THE CATHETER/CANNULA WAS KNOWN TO BEND AND CRIMP VERY EASILY AND THIS WAS VALIDATED WITH DEMONSTRATION ON THE SAME TYPE OF CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646001 SURFLO IV CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ TERUMO MEDICAL CORP. SURFLO

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other