BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAY THORACENT W/CATH 14GAX2

    MDR report key: 586822 · Received March 30, 2005

    Report

    Report Number
    1423507-2005-00047
    Event Type
    Injury
    Date Received
    March 30, 2005
    Date of Event
    November 2, 2004
    Report Date
    March 30, 2005
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GCB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THERE WAS AN INJURY AS A RESULT OF USING THE 4341B. SOMETHING ON THE DEVICE BROKE OFF AND WAS LEFT IN THE PATIENT. THEY STATED THAT IN 2004, DURING A THORACENTESIS PROCEDURE, THE DOCTOR PULLED BACK ON THE NEEDLE AND NOTICED THE CATHETER HAD SHEERED ALL LEAVING ABOUT SEVEN CENTER METERS INSIDE THE PT. THE PATIENT WAS SENT TO RADIOLOGY TO CONFIRM THE PIECE WAS INSIDE THE BODY. THEY STATED THE BROKEN PIECE WAS REMOVED FROM THE PATIENT SIX DAYS LATER; BOTH PIECES OF THE PRODUCT WILL BE RETURNED FOR EVALUATION. THE PT WAS GIVEN ANTIBIOTICS AND IS DOING WELL REP FURTHER STATED THE PT HAS BEEN IN FOR SEVERAL THORACENTESIS PROCEDURES IN THE PAST FEW MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAY THORACENT W/CATH 14GAX2 THORACENT GCB CARDINAL HEALTH 4341B L3H125

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other