BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN CHEST DRAINAGE SYSTEM

    MDR report key: 2180839 · Received July 21, 2011

    Report

    Report Number
    3004365956-2011-00279
    Event Type
    Death
    Date Received
    July 21, 2011
    Report Date
    July 8, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KDQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: THE DHR COULD NOT BE PERFORMED, BECAUSE, THE LOT NUMBER WAS UNK. THE SAMPLE WAS NOT AVAILABLE, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. CONCLUSIONS: NO EVALUATION WILL BE PERFORMED. IF THE SAMPLE BECOMES AVAILABLE, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: A FRIEND OF AN EMPLOYEE OF TELEFLEX INFORMED THE EMPLOYEE THAT WHILE VISITING HER FATHER'S BEDSIDE, SHE NOTICED FLUID LEAKING ONTO THE FLOOR FROM A CHEST DRAINAGE DEVICE WITH TELEFLEX'S NAME ON IT. THE FATHER EXPIRED ON (B)(6) 2011, BUT NOT DUE TO COMPLICATIONS FROM THE CHEST DRAINAGE DEVICE. THE PT HAD MULTI-ORGAN FAILURE FOLLOWING EMERGENCY SURGERY. NO FURTHER INFO IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death