BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEURAGUIDE KIT

    MDR report key: 3961608 · Received June 16, 2014

    Report

    Report Number
    1219977-2014-00215
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    KDQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING THE RETURN OF THE DEVICE FOR EVAL. A FOLLOW-UP REPORT SHALL BE SUBMITTED UPON THE COMPLETION OF THE EVAL.

    Description of Event or Problem · 1

    RECEIVED A REPORT THAT AFTER A CHEST TUBE WAS INSERTED IN THE PT, A PIECE OF THE SMALL KELLY CLAMP BROKE OFF INSIDE THE PTS CHEST AS IT WAS BEING REMOVED. THE CLAMP WAS BEING USED TO HOLD TISSUE AT THE INCISION SITE. THE PIECE WAS ABLE TO BE RETRIEVED AND NO HARM TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353260 PLEURAGUIDE KIT BOTTLE, COLLECTION, VACUUM KDQ ATRIUM MEDICAL CORP. 17100 204296

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention