BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENTRIFLEX FEEING TUBES

    MDR report key: 4017598 · Received August 12, 2014

    Report

    Report Number
    9612030-2014-00046
    Event Type
    Other
    Date Received
    August 12, 2014
    Date of Event
    July 12, 2014
    Report Date
    July 23, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FPD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    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)(4) 2014, THAT A CUSTOMER HAD AN ISSUE WITH A FEEDING TUBE. THE CUSTOMER REPORTS THAT THERE WAS AN INCIDENT OF A PATIENT WITH THE DH TUBE INSERTED THROUGH THE LUNG. THE NURSES REPORTED THEY FOLLOWED ALL DIRECTIONS, SOAKING IT IN WATER PRIOR TO INSERTION. THE CUSTOMER ALSO STATED THAT THERE WAS NO MORE RESISTANCE MET THAN USUAL WHEN INSERTING THE TUBE. ON (B)(6) 2014, THE PATIENT WAS A (B)(6) FEMALE WITH AN ALTERED MENTAL STATUS FOR 5-6 DAYS AT HOME, POSSIBLE SEIZURE FROM BENZODIAZEPINE AND NARCOTIC WITHDRAWAL. THE PATIENT WAS CONSCIOUS BUT LETHARGIC AND DID NOT FOLLOW COMMANDS. THE PLACEMENT WAS THROUGH THE RIGHT NARE, NO DIFFICULTY, AND PER THE NURSE, SOME COUGHING FROM THE PATIENT BUT NOTHING ALARMING. A POST PLACEMENT X-RAY SHOWED MODERATE RIGHT PNEUMOTHORAX REQUIRING PLACEMENT OF A CHEST TUBE. THE CHEST TUBE WAS REMOVED ON (B)(6) 2014 AND THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2014 IN STABLE CONDITION. NO FORMULA WAS FED INTO THE LUNGS, AS A POST-PLACEMENT X-RAY IS REQUIRED PRIOR TO USE FOR ALL DOBB-HOFF TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479253 ENTRIFLEX FEEING TUBES ENTERAL FEEDING TUBE FPD COVIDIEN 8884721088 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other