BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLUER-EVAC SAHARA INFANT DRY DRAINAGE SYSTEM

    MDR report key: 1727136 · Received June 14, 2010

    Report

    Report Number
    3004365956-2010-00095
    Event Type
    Death
    Date Received
    June 14, 2010
    Date of Event
    May 14, 2010
    Report Date
    May 14, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KDQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE IS AVAILABLE FOR INVESTIGATION, BUT HAS NOT BEEN RECEIVED IN TIME FOR THIS REPORT. THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THE EVENT AS: WHEN THE DEVICE WAS USED, THE NURSING STAFF NOTICED MOISTURE IN THE DRAIN. THEY COULD NOT DETERMINE WHERE THE MOISTURE WAS COMING FROM. ULTIMATELY, THEY DID NOT THINK IT WAS DEVICE RELATED. ALTHOUGH THE PT DIED, THE STAFF DID NOT ATTRIBUTE THE DEATH TO THE DEVICE, BUT RATHER TO OTHER CIRCUMSTANCES THAT LEAD TO THE INFANT'S DEATH. NO FURTHER INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUER-EVAC SAHARA INFANT DRY DRAINAGE SYSTEM INFANT CHEST DRAINAGE SYSTEM KDQ TELEFLEX MEDICAL NA 02L0500324

    Patients

    Seq Age Sex Outcome Treatment
    1 Death