BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEUREVAC ADULT/PED DRY/WET LF

    MDR report key: 3190587 · Received June 21, 2013

    Report

    Report Number
    3004365956-2013-00198
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 30, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY REPORT (DHR) WAS REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND THAT COULD POTENTIALLY RELATE TO THIS COMPLAINT. DHR SHOWS THAT THE PRODUCT WAS PACKED AND INSPECTED ACCORDING TO SPECIFICATIONS. NO REJECTION REPORT WERE ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. CUSTOMER COMPLAINT CAN NOT BE CONFIRMED DUE THE LACK OF PRODUCT SAMPLE TO PERFORM A PROPER INVESTIGATION AND DETERMINATE THE ROOT CAUSE. IF THE DEFECTIVE SAMPLES BECOME AVAILABLE AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: COMPLAINT ALLEGES: WHEN THE USER OPENED THE BOX, HE NOTICED THAT ONE OF THE PLASTIC BAGS OF ONE PLEUR EVAC HAD A HOLE ON THE RIGHT SIDE. THE USER TOOK ANOTHER UNIT (SAME BOX): NO OTHER ISSUE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282564 PLEUREVAC ADULT/PED DRY/WET LF PLEUREVAC DRAINAGE SYSTEM CAC TELEFLEX MEDICAL 02L1200852

    Patients

    Seq Age Sex Outcome Treatment
    1