BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACENTESIS KIT

    MDR report key: 2436944 · Received January 18, 2012

    Report

    Report Number
    1036844-2012-00025
    Event Type
    Malfunction
    Date Received
    January 18, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 17, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    JOL
    PMA / PMN Number
    K870572
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE KIT WAS OPENED THEY FOUND THE LIDOCAINE AMPULE WAS BROKEN IN THE KIT. AS A RESULT, THEY PULLED THE EXTRA AMPULE OF LIDOCAINE FROM THEIR STOCK AND THE PROCEDURE WAS PERFORMED SUCCESSFULLY FOR THE PT. THERE WAS A 5 MIN DELAY IN TREATMENT WITH NO HARM TO THE PT, NO PT DEATH, AND NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORACENTESIS KIT THORACIC CATHETER PRODUCTS JOL ARROW INTL., INC. RF1094757

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK