BEUDAMED
    FDA Adverse Event Other Summary report: N

    12FR 24CM MAHKR TLC KIT SGT EXT X5

    MDR report key: 2860233 · Received November 26, 2012

    Report

    Report Number
    1317749-2012-00301
    Event Type
    Other
    Date Received
    November 26, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 1, 2012
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTED THE PT HAD A DIALYSIS CATHETER AND A CENTRAL LINE PLACED AT THE SAME SITE WITHIN THE FEMORAL ARTERY. SCANS WERE PERFORMED AND THE RADIOLOGIST INJECTED 100 ML OF IV CONTRAST AND WAS UNSURE IF HE USED THE DIALYSIS CATHETER OR THE CENTRAL LINE TO DO SO. CONTRAST EXTRAVASATION WAS NOTICED. SWELLING AND INFLAMMATION OCCURRED AFTERWARDS. BOTH LINES WERE THEN REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12FR 24CM MAHKR TLC KIT SGT EXT X5 DIALYSIS CATHETER MPB COVIDIEN 8888340637 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other