BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACENTESIS KIT

    MDR report key: 1884221 · Received June 11, 2010

    Report

    Report Number
    1036844-2010-00061
    Event Type
    Malfunction
    Date Received
    June 11, 2010
    Date of Event
    June 22, 2009
    Report Date
    April 20, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    JOL
    PMA / PMN Number
    K870572
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL. THIS IS ONE OF 3 RECORDS REFLECTING MULTIPLE OCCURRENCES (B)(4). ADDITIONAL OCCURRENCES ARE DOCUMENTED AS MDR #1036844-2009-00154, MDR# 1036844-2010-00060. UNTIL JULY 27, 2009, MULTIPLE OCCURRENCES WERE REPORTED ON A SINGLE MDR. THEY ARE NOW REPORTED AS INDIVIDUAL EVENTS. ALL MULTIPLE OCCURRENCES FROM JANUARY 1, 2009 THROUGH JULY 27, 2009 ARE BEING REMEDIATED TO INCLUDE THE CORRECT NUMBER OF COMPLAINTS, MDRS, VIGILANCE, AND (B)(4) REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT IN THIS INSTANCE, WHILE THE PHYSICIAN WAS ASPIRATING USING THE 60CC SYRINGE, FLUID WAS LEAKING FROM THE BACK OF THE SYRINGE. IT WAS NOTED THE BLACK PLUNGER DOES NOT APPEAR TO BE SEALED PROPERLY. THERE HAVE BEEN NO PT COMPLICATIONS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK