BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS SET: 2-L 15 FR X 24 CM

    MDR report key: 2241160 · Received August 17, 2011

    Report

    Report Number
    1036844-2011-00272
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 9, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    MSD
    PMA / PMN Number
    K040078
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS BEING PLACED INTO THE PT'S RIGHT INTERNAL JUGULAR IN THE ACCESS CENTER. AFTER THE CATHETER WAS PULLED THROUGH THE EXIT SITE, THE TUNNELER DISCONNECTED AND THE CAP AND COMPRESSION SLEEVE DROPPED OFF. AS A RESULT, ANOTHER KIT WAS OPENED TO REPLACE THE COMPRESSION CAP AND SLEEVE. THERE WAS NO DELAY IN TREATMENT, NO PT DEATH AND NO PT COMPLICATIONS WERE REPORTED. THE PT RECEIVED A SUCCESSFUL PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMODIALYSIS SET: 2-L 15 FR X 24 CM CHRONIC HEMODIALYSIS CATHETER PRODUCTS MSD ARROW INTL., INC. RF1046339

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK