BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARACENTESIS KIT

    MDR report key: 3021033 · Received March 20, 2013

    Report

    Report Number
    1036844-2013-00097
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 18, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    KDD
    PMA / PMN Number
    K874063
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CLINICIAN INDICATED THE STOPCOCK LEAKED UPON INSERTION. IT IS NOT KNOWN IF ANYTHING WAS EXCHANGED FOR THE PT. THEY DO NOT KNOW IF THERE WAS A DELAY IN TREATMENT AND NO PT DEATH OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115768 PARACENTESIS KIT EMERGENCY/TRAUMA PRODUCTS KDD ARROW INTL., INC. RF2096426

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK