BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIP LUM CATH KITS 16CM X 5

    MDR report key: 1845027 · Received September 8, 2010

    Report

    Report Number
    1317749-2010-00242
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    October 19, 2009
    Report Date
    August 27, 2010
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2010. 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)(6) 2010, THAT A CUSTOMER HAD AN ISSUE WITH A TRIPLE LUMEN CATHETER. AFTER INSERTION OF THE CATHETER, IT WAS POSSIBLE TO FLUSH AND ASPIRATE BLOOD AT ALL THREE LUMEN. AFTER A TRANSPORT WITHIN THE HOSPITAL, IT WAS NO LONGER POSSIBLE TO ASPIRATE BLOOD THROUGH THE BROWN CONNECTOR. INJECTED NAC1 LEAKED THROUGH A 3 MM RIP OUT OF THE TUBE. PT DEVELOPED A BLOOD-PRESSURE AND OXYGEN SATURATION DECLINE, BUT IT WAS POSSIBLE TO STABILIZE HIM. PT SPENT ONE NIGHT IN THE INTENSIVE CARE UNIT BECAUSE OF SUSPICION OF AIR EMBOLIZATION. NO PERMANENT HARM IN STATE OF HEALTH WAS NOTICED. CATHETER WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIP LUM CATH KITS 16CM X 5 TRIPLE LUMEN CATHETER MPB COVIDIEN 8888345611 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK