BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5FR URETHANE UMB CATH

    MDR report key: 3933741 · Received April 2, 2014

    Report

    Report Number
    1317749-2014-00166
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Report Date
    March 10, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A SINGLE LUMEN UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER REPORTS THAT THE UVC WAS PLACED ON (B)(6) 2014. UPON BEGINNING HER SHIFT AT 7:00 AM, IT WAS NOTED THAT THE LINENS WERE DAMP UNDER THE CATHETER. NO BLOOD WAS NOTED INITIALLY AND SHE WAS UNABLE TO DETERMINE THE SOURCE OF THE MOIST LINENS. A LITTLE WHILE LATER, SHE WENT BACK TO CHECK ON THE PATIENT AND NOTICED BLOOD BACKING UP INTO THE UVC CATHETER AND NOTICED SCANT AMOUNTS OF BLOOD ON THE LINENS. AT THIS POINT, SHE WIPED OFF THE CATHETER AND THE CATHETER HUB (AS THIS WAS WHERE THE CATHETER WAS WET) AND HELD IT UP SO SHE COULD VISUALIZE THE LEAK. SHE COULD SEEN DROPS OF IV FLUID MIXED WITH BLOOD DRIPPING FROM THE UVC CATHETER. IT WAS LEAKING FROM THE POINT WHERE THE UVC CATHETER TUBING CONNECTS TO THE FEMALE PORT/HUB WHICH WOULD THEN CONNECT TO THE IV FLUID FILTER AND TUBING. THE UVC CATHETER WAS SUBSEQUENTLY CLAMPED OFF UNTIL IT COULD BE REMOVED AND THEY COULD ATTEMPT ANOTHER UVC INSERTION OR PICC INSERTION. AFTER THE CATHETER WAS REMOVED, THE TUBING WAS FLUSHED TO GET AN EVEN BETTER PICTURE OF THE LEAK. THERE WAS NO DOUBT THAT THE CATHETER TUBING HAD DEFINITELY PARTIALLY COME APART FROM THE FEMALE HUB/PORT ON THE CATHETER. THE CUSTOMER REPORTS THAT THEY COULD EVEN SEE A SLIT IN THE CATHETER TUBING WHERE THE LEAK WAS COMING FROM. THE AMOUNT OF BLOOD LOSS WAS MINIMAL. THEY WOULD ESTIMATE LESS THAN 3ML. THERE WAS NO EXTENSION TUBING IN USE. THERE WAS NO BUFF-CAP OR CLAVE. THE UVC CATHETER WAS CONNECTED TO A FILTER FOLLOWED BY IV FLUID TUBING WHICH WAS CONNECTED TO AN IV FLUID BAG. THE CUSTOMER REPORTS THAT THEY DO NOT RECALL THE RATE OF THE FLUID, IT WAS DEFINITELY LESS THAN 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196902 3.5FR URETHANE UMB CATH UMBILICAL VESSEL CATHETER FOS COVIDIEN 8888160333 235203X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK