BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACENTESIS KIT

    MDR report key: 3102284 · Received May 1, 2013

    Report

    Report Number
    1036844-2013-00160
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 30, 2013
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    JOL
    PMA / PMN Number
    K870572
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    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 THAT WHEN THE KIT WAS OPENED, THEY FOUND THE LIDOCAINE AMPULE WAS BROKEN IN THE TRAY. AS A RESULT, THEY USED HOSPITAL STOCK OF LIDOCAINE TO COMPLETE THE PROCEDURE. THEY DO NOT KNOW IF THIS CAUSED A DELAY IN TREATMENT AND THERE WAS NO PT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189299 THORACENTESIS KIT THORACIC CATHETER PRODUCTS JOL ARROW INTERNATIONAL INC RF2108974

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK