BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEUR-EVAC CHEST DRAINAGE SYSTEM, DRY SUCTION

    MDR report key: 2090158 · Received April 11, 2011

    Report

    Report Number
    3004365956-2011-00144
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Report Date
    March 21, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KDQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS, EVALUATION OF THE PRODUCT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED, HOWEVER, SUCH A LEAK COULD BE GENERATED DUE TO DAMAGES ON THE UNIT SUCH AS IMPACT, BAD ASSEMBLY, OR DEFECT ON THE COMPONENTS. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. CONCLUSIONS: DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. NO CORRECTIVE ACTION REQUIRED DUE TO LACK OF SAMPLE AND UNKNOWN LOT NUMBER. AS A PREVENTATIVE ACTION SINCE (B)(4) 2010, ALL UNITS ARE 100% TESTED FOR LEAKAGE IN THE MANUFACTURING LINE IN ORDER TO CONFIRM THAT THE TUBING DRAIN SYSTEM IS FREE FROM AIR LEAKS. IF ADDITIONAL INFORMATION ON THIS COMPLAIN IS OBTAINED OR A SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT "THE CHEST DRAIN MAY HAVE AN AIR LEAK. AIR LEAK GOES AWAY WHEN THE DRAIN IS REPLACED." NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEUR-EVAC CHEST DRAINAGE SYSTEM, DRY SUCTION PLEUR-EVAC CHEST DRAINAGE SYSTEM KDQ TELEFLEX MEDICAL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1