BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUTE TRIPLE LUMEN CATH 16CM

    MDR report key: 1910844 · Received November 23, 2010

    Report

    Report Number
    1317749-2010-00318
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 31, 2010
    Report Date
    November 1, 2010
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 11/23/2010. AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 11/01/2010, THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. THE CUSTOMER REPORTS BROKEN TUBING AT VENOUS CONNECTOR HUB. DIALYSIS WAS TERMINATED, AND THE NURSE REALIZED THAT THERE WAS A BACK FLOW OF BLOOD FROM THE CATHETER. WHEN SHE TRIED TO FLUSH, SHE DISCOVERED THAT THE TUBING WAS BROKEN. CATHETER WAS REMOVED AND BLOOD CLOT WAS OBSERVED AT THE TIP OF THE CATHETER. THE CATHETER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUTE TRIPLE LUMEN CATH 16CM HEMODIALYSIS CATHETER MPB COVIDIEN 8888345611 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR