BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10FR X 55" ENTRIFLEX W/STYLET

    MDR report key: 4131862 · Received October 1, 2014

    Report

    Report Number
    9612030-2014-00059
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    February 12, 2014
    Report Date
    September 18, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FPD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE CONDUCTED BECAUSE A LOT NUMBER WAS NOT PROVIDED. MANUFACTURING RECORDS ARE ROUTINELY REVIEWED PRIOR TO THE RELEASE OF PRODUCT TO ENSURE PROCESS AND PRODUCT COMPLIANCE. THE SAMPLE WAS NOT PROVIDED FOR EVALUATION. THE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT. IN THE WARNING SECTION WITHIN THE INSTRUCTION FOR USE (IFU), ADVERSE EFFECTS LIKE PNEUMOTHORAX, INTESTINAL PERFORATION AND ASPIRATIONAL PNEUMONIA HAVE BEEN REPORTED DURING THE USE OF THIS TYPE OF DEVICE, THEREFORE DUE TO THE EXTREME CAUTION; THIS DEVICE SHOULD ONLY BE INSERTED BY A TRAINED CLINICIAN. ADDITIONALLY, BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE PATIENT IN THIS EVENT HAD THE DUODENUM TOO VERTICAL WHICH COULD BE A PROBABLE ROOT CAUSE FOR THIS ISSUE. THE PROCESS TO MANUFACTURE THE DEVICE WAS RUNNING ACCORDING TO THE DEFINED PARAMETERS AND SPECIFICATIONS. THE PRODUCTS MET THE CORRESPONDING QUALITY ACCEPTANCE CRITERIA. THE PRODUCTION PERSONNEL WERE NOTIFIED ABOUT THE REPORTED CONDITION. BASED ON THE INFORMATION, A CORRECTIVE ACTION FROM A PRODUCTION PERSPECTIVE IS NOT DEEMED NECESSARY AT THIS TIME. WE WILL CONTINUE MONITORING THE PROCESS FOR ANY ADVERSE TRENDS THAT REQUIRE IMMEDIATE ATTENTION. IF ADDITIONAL INFORMATION IS RECEIVED WARRANTING FURTHER ANALYSIS, THE INVESTIGATION WILL BE RESUMED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(46) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A FEEDING TUBE. THE CUSTOMER REPORTS AN INTESTINAL PERFORATION COINCIDENT WITH DUODOPA THERAPY. ON (B)(6) 2014 THE PEG WAS GOING TO BE PERFORMED. THIS WAS A NEW PATIENT IN DUODOPA THERAPY. DURING THE PROCEDURE, AN INTESTINAL PERFORATION (IN DUODENUM) WAS PERFORMED. THE INTERNAL TUBE WAS REMOVED. THE DUODOPA WILL BE ADMINISTERED THROUGH THE EXTERNAL TUBE DIRECTLY TO THE STOMACH. WHEN ASKED IF THERE WAS ANATOMICAL CONDITIONS THAT COULD PREDISPOSE THE PATIENT TO THE EVENT AND THE REPORTER STATED THAT THE PATIENT HAD THE DUODENUM TOO VERTICAL. INTESTINAL PERFORATION IN DUODENUM/SMALL INTESTINAL PERFORATION, DUODOPA WAS ADMINISTERED THROUGH THE EXTERNAL TUBE DIRECTLY TO THE STOMACH, INCORRECT ROUTE OF DRUG ADMINISTRATION, VOMITING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611848 10FR X 55" ENTRIFLEX W/STYLET FEEDING TUBE FPD COVIDIEN 8884721055

    Patients

    Seq Age Sex Outcome Treatment
    1 Other