BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS KIT: 2-L 15 FR X 23 CM

    MDR report key: 3250138 · Received July 24, 2013

    Report

    Report Number
    1036844-2013-00250
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 8, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    MSD
    PMA / PMN Number
    K040078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DIALYSIS, THE EXTENSION LINE WAS FOUND LEAKING AND WAS NOT ALLOWING NORMAL DIALYSIS. AS A RESULT, A REPLACEMENT KIT WAS USED WITHOUT ISSUE. IT IS NOT KNOWN IF A DELAY RESULTED, HOWEVER, THERE WAS NO REPORTED DEATH OR COMPLICATIONS AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346101 HEMODIALYSIS KIT: 2-L 15 FR X 23 CM CATHETER, HEMODIALYSIS, IMPLANTABLE MSD ARROW INTL., INC. RF2019981

    Patients

    Seq Age Sex Outcome Treatment
    1