BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRAY THORACENT W/CATH 14GAX2

    MDR report key: 596282 · Received April 26, 2005

    Report

    Report Number
    1423507-2005-00055
    Event Type
    Other
    Date Received
    April 26, 2005
    Date of Event
    March 28, 2005
    Report Date
    April 26, 2005
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GCB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS PERFORMING A THORACENTESIS WHEN THE CATHETER BROKE OFF IN THE PATIENT. THE PHYSICIAN HAD INSERTED THE NEEDLE INTO THE PLEURAL SPACE; HE NOTICED WHEN HE WAS DRAWING BACK THAT THERE WERE AIR BUBBLES THAT CAME INTO THE SYRINGE ALONG WITH THE PLEURAL FLUID. HE ADVANCED THE CATHETER, DREW OUT AND THERE WAS NOTHING BUT THE NEEDLE AND 1/2 CM BRITTLE CATHETER. THE PHYSICIAN FURTHER STATED THAT IT WAS LIKE THE CATHETER PULVERIZED. HE ALSO ADDED THAT THE CATHETER IS SUPPOSED TO BE ABOUT 8-10 INCHES LONG. THE BROKEN PIECE IS STILL INSIDE OF THE PATIENT. THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION. ACCOUNT FURTHER STATED THAT THEY DO NOT HAVE ANY PRODUCT WITH THE SAME LOT NUMBER AS THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAY THORACENT W/CATH 14GAX2 THORACENTESIS GCB CARDINAL HEALTH 4341B L3E160

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Other