BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACENTESIS KIT

    MDR report key: 2935629 · Received January 23, 2013

    Report

    Report Number
    1036844-2013-00027
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 23, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    JOL
    PMA / PMN Number
    K870572
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE KIT WAS OPENED THEY DISCOVERED THE LIDOCAINE AMPULE WAS BROKEN. AS A RESULT, THE KIT WAS DISCARDED AND A NEW KIT WAS USED SUCCESSFULLY. THERE WAS NO DELAY IN TREATMENT AND NO PATIENT DEATH OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33393 THORACENTESIS KIT THORACIC CATHETER PRODUCTS JOL ARROW INTL., INC. RF2071669

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK