BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORACENTESIS SET

    MDR report key: 3093732 · Received May 1, 2013

    Report

    Report Number
    1036844-2013-00164
    Event Type
    Injury
    Date Received
    May 1, 2013
    Date of Event
    April 4, 2013
    Report Date
    May 1, 2013
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    JOL
    PMA / PMN Number
    K870572
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROCEDURE WAS BEING PERFORMED IN THE EMERGENCY ROOM. THE PLEURA-SEAL THORACENTESIS SET WAS INSERTED AND AFTERWARDS, THE PT WAS SENT TO HAVE AN X-RAY AS A ROUTINE. AT WHICH TIME, THERE WAS A PNEUMOTHORAX AS A RESULT OF THE INSERTION. IT IS NOT KNOWN IF THERE WAS A DELAY IN TREATMENT AND THERE WAS NO PT DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189734 THORACENTESIS SET THORACIC CATHETER PRODUCTS JOL ARROW INTERNATIONAL INC. RF1082481

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention