BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACENTESIS KIT

    MDR report key: 1915555 · Received November 5, 2010

    Report

    Report Number
    1036844-2010-00331
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    JOL
    PMA / PMN Number
    K870572
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REFERENCE MDR #1036844-2010-00330 FOR THE FIRST EVENT INVOLVING THE SAME PT. IT WAS REPORTED THAT THE PHYSICIAN INSERTED THE SECOND THORACENTESIS CATHETER INTO THE PT'S BACK. AGAIN, UPON ASPIRATION VIA VACUUM TUBING, THEY REPORTED "GURGLING" FROM THE BLUE RUBBER SEAL. AS A RESULT, A THIRD KIT WAS OPENED AND USED SUCCESSFULLY. THERE WAS NO DELAY IN TREATMENT, NO PT DEATH AND NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORACENTESIS KIT THORACIC CATHETER PRODUCTS JOL ARROW INTL., INC. RF8096230

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK