BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACENTESIS TRAY 14G X 2 W/CATH

    MDR report key: 2286421 · Received October 11, 2011

    Report

    Report Number
    1625685-2011-00022
    Event Type
    Malfunction
    Date Received
    October 11, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    CAREFUSION
    Product Code
    GCB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN ADDITION, ON 09/12/2011 AN FDA INQUIRY DATED 08/31/2011 WAS RECEIVED FOR THIS EVENT BASED OFF OF A MAUDE DATABASE REPORT (USER FACILITY REPORT NO. (B)(4)).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE PHYSICIAN WAS PERFORMING A THORACENTESIS WITH A THORACENTESIS WITH CATHETER TRAY (PRODUCT NUMBER 4341B) IN THE INTENSIVE CARE UNIT (ICU), THE NEEDLE CAME OFF OF THE HUB WHEN FLUID WAS INJECTED. THE NEEDLE BROKE OFF INTO THE PATIENT. HOWEVER, THE CHARGE NURSE HAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT, INJURY, OR MEDICAL INTERVENTION AS THE PHYSICIAN WAS ABLE TO REMOVE THE NEEDLE OUT OF THE PATIENT WITHOUT ANY FURTHER PROBLEMS. THE SAMPLE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORACENTESIS TRAY 14G X 2 W/CATH THORACENTESIS TRAY WITH CATHETER GCB CAREFUSION 4341B 0000330580

    Patients

    Seq Age Sex Outcome Treatment
    1