BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS SET: 2-LUMEN 12 FR X 20CM

    MDR report key: 3960066 · Received May 29, 2014

    Report

    Report Number
    1036844-2014-00234
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 22, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    MPB
    PMA / PMN Number
    K991431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WA REPORTED THAT IN DIALYSIS/HEMO PRIOR TO USE, THE TIP OF THE SWG WAS FOUND DEFORMED. AS A RESULT, A NEW KIT WAS OPENED AND USED WITHOUT ISSUE. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PATIENT A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315560 HEMODIALYSIS SET: 2-LUMEN 12 FR X 20CM ACTURE HEMODIALYSIS CATHETER PRODUCTS MPB ARROW INTL., INC. 23F13L0221

    Patients

    Seq Age Sex Outcome Treatment
    1