BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 12 FR X 20 CM

    MDR report key: 3900307 · Received May 2, 2014

    Report

    Report Number
    1036844-2014-00209
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    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 WAS REPORTED THAT IN HEMODIALYSIS DURING INSERTION, THE TIP OF THE DILATOR WAS FOUND INDENTED AND AS A RESULT THE SWG COULD NOT BE PASSED THROUGH IT. A NEW KIT WAS OPENED AND USED WITHOUT ISSUE. 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
    265441 CVC SET: 3-LUMEN 12 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. 23F13H0141

    Patients

    Seq Age Sex Outcome Treatment
    1