BEUDAMED
    FDA Adverse Event Death Summary report: N

    RUSCH ENTERAL FEEDING TUBE WITH STYLET

    MDR report key: 1045964 · Received May 16, 2008

    Report

    Report Number
    3004365956-2008-00015
    Event Type
    Death
    Date Received
    May 16, 2008
    Report Date
    May 6, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FPD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED TO THE MFR FOR EVAL. THE DEVICE WAS SENT TO FACILITY FOR INVESTIGATION BY THE DISTRIBUTOR. DHR REVIEW: BASED ON LOT # 087620-1; NO ISSUES RELATED TO THE REPORTED COMPLAINT DESCRIPTION WERE FOUND. THE DHR INDICATES THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. ALSO NO DIRECT ROOT CAUSE CAN BE ESTABLISHED. THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SENT AS SOON AS IS AVAILABLE.

    Description of Event or Problem · 1

    COMPLAINT REPORTED: THE WEIGHTED END OF THE ENTUBE BROKE OFF IN THE PT UPON INSERTION. PT STARTED COUGHING VIOLENTLY AND ASPIRATED THE TIP. PT HAD TO HAVE A BRONCHOSCOPY, WHICH TOOK SIX HOURS, TO REMOVE TIP FROM THE RIGHT LOBE. IT WAS SUCCESSFULLY RETRIEVED. IN 2008: AFTER SEVERAL DOCUMENTED ATTEMPTS TO CONTACT DOCTOR, HE RETURNED OUR CALL ON THIS DAY. IT WAS REPORTED THE PT HAD BEEN IN INTENSIVE CARE UNIT PRIOR TO ATTEMPTED INSERTION OF FEEDING TUBE WITH CONGESTIVE HEART FAILURE AND HAD A TRACHEOTOMY. PT DIED 72 HOURS AFTER BRONCHOSCOPY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH ENTERAL FEEDING TUBE WITH STYLET FEEDING TUBE FPD TELEFLEX MEDICAL 087620-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R