BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T CENTESIS 6 FR CATHETER DRAINAGE TRAY

    MDR report key: 1353094 · Received March 27, 2009

    Report

    Report Number
    MW5010502
    Event Type
    Malfunction
    Date Received
    March 27, 2009
    Date of Event
    March 19, 2009
    Report Date
    March 27, 2009
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THORACENTESIS TRAY HAS AIRLEAK IN WHITE TUBING WHERE THE STYLET IS REMOVED FROM THE TUBE ENTERING THE PT. AIR IS PULLED INTO THE EVACUTAINER. IF THUMB IS PLACED FIRMLY OVER THIS AREA AIR CAN USUALLY BE STOPPED. THIS SHOULD BE A CLOSED SYSTEM. WE HAVE BEEN HAVING PROBLEMS WITH THESE TRAYS RECENTLY, SO ALL LOT NUMBERS HAVE BEEN RETURNED TO THE MANUFACTURER. ONLY ONE WAS USED ON THIS PATIENT - THE LOT NUMBER PROVIDED IN THIS REPORT MIGHT NOT BE THEN EXACT LOT NUMBER UTILIZED ON THIS PATIENT, BUT WE DID NOT HAVE THE EXACT NUMBER. THIS PATIENT WAS NOT HARMED, BUT THERE IS POTENTIAL FOR HARM. IT APPEARS WE ARE HAVING DIFFICULTY WITH MULTIPLE LOT NUMBERS AT PRESENT - ONLY ONE FOR THIS PATIENT-, SO ALL ARE BEING RETURNED TO THE MANUFACTURER FOR REVIEW. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: THORACENTESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFE-T CENTESIS 6 FR CATHETER DRAINAGE TRAY THORACENTESIS TRAY KDQ CARDINAL HEALTH L9A316

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR