BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-CENTESIS TRAY 6FR X 16CM

    MDR report key: 2332042 · Received November 10, 2011

    Report

    Report Number
    1625685-2011-00031
    Event Type
    Malfunction
    Date Received
    November 10, 2011
    Date of Event
    September 13, 2011
    Report Date
    October 11, 2011
    Manufacturer
    CAREFUSION
    Product Code
    GCB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS TWO EVENTS WERE NOTED IN THE USER FACILITY MEDWATCH REPORT, THIS IS REPORT ONE OF TWO.

    Additional Manufacturer Narrative · 1

    (B)(4). A SECOND FDA INQUIRY DATED (B)(4) 2011 WAS RECEIVED ON (B)(4) 2011.

    Description of Event or Problem · 1

    AN FDA INQUIRY DATED (B)(4) 2011 WAS RECEIVED ON (B)(4) 2011 CITING USER FACILITY MEDWATCH ((B)(4)). THE REPORT INDICATED THE FOLLOWING AS REPORTED BY THE CUSTOMER: THE NEEDLE BECAME DETACHED FROM THE HUB AS THE PHYSICIAN WAS INSERTING THE SYRINGE INTO THE PATIENT DURING A THORACENTESIS. FLUID SPRAYED THROUGHOUT THE ROOM. THE FIRST INCIDENT OCCURRED IN MID (B)(6) AND A SUBSEQUENT EVENT OCCURRED 3 DAYS LATER. AN ALLIED HEALTH PROFESSIONAL WAS INVOLVED IN THE SECOND INCIDENT. BOTH SAFE-T-CENTESIS CATHETER DRAINAGE TRAYS WERE FROM THE SAME LOT NUMBER. DESPITE SEVERAL ATTEMPTS MADE BY CAREFUSION TO OBTAIN ADDITIONAL INFORMATION, NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFE-T-CENTESIS TRAY 6FR X 16CM NEEDLE, CATHETER GCB CAREFUSION PIG1260T 0000342638

    Patients

    Seq Age Sex Outcome Treatment
    1