BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3-L CVC KIT: 7 FR X 20 CM

    MDR report key: 3915443 · Received February 25, 2014

    Report

    Report Number
    1036844-2014-00091
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 19, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K993691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION OF THE SWG INTO THE ARS, RESISTANCE WAS MET CAUSING THE SWG TO KINK. AS A RESULT, BOTH THE SWG AND ARS WERE REMOVED AT WHICH TIME THE SWG UNRAVELED. THE SWG WAS REMOVED IN ITS ENTIRETY, AND A NEW KIT WAS OPENED AND USED; HOWEVER, THE SAME ISSUE OCCURRED. SEE MDR 1036844-2014-00092 FOR THE SECOND OCCURRENCE. 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
    115486 3-L CVC KIT: 7 FR X 20 CM ARROW G+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1