BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 12 FR X 20 CM

    MDR report key: 3080939 · Received April 24, 2013

    Report

    Report Number
    3006425876-2013-00051
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 22, 2013
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    MPB
    PMA / PMN Number
    K991431
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN NEPHROLOGY WHEN REMOVING THE SWG FROM THE CATHETER AFTER IT WAS INSERTED, THE SWG UNRAVELED. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176235 CVC SET: 2-LUMEN 12 FR X 20 CM ACUTE HEMODIALYSIS CATHETER PRODUCTS MPB ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK