BEUDAMED
    FDA Adverse Event Death Summary report: N

    10FR 43 IRIS FEEDING TUBE ENF

    MDR report key: 15160266 · Received August 3, 2022

    Report

    Report Number
    1282497-2022-10710
    Event Type
    Death
    Date Received
    August 3, 2022
    Date of Event
    April 22, 2022
    Report Date
    August 3, 2022
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KNT
    UDI-DI
    20884521742199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT AND SERIAL NUMBERS WERE NOT RECEIVED WITH THE COMPLAINT. HOWEVER, AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO THE RELEASE OF PRODUCT. A SAMPLE WAS NOT RECEIVED FOR INVESTIGATION. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THE EVENT. ACCORDING TO THE CUSTOMER'S REPORT, IT SEEMS THAT THE PROBLEM WAS NOT CAUSED BY THE PRODUCT ITSELF. IF A SAMPLE IS RECEIVED AT A LATER DATE, THE COMPLAINT WILL BE REOPENED, AND THE INVESTIGATION WILL BE UPDATED ACCORDINGLY. A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME. FUNCTIONAL TESTING AND VISUAL INSPECTIONS ARE BEING PERFORMED ACCORDING TO OUR CURRENT QUALITY STANDARDS AND INSPECTION PROCEDURES. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE PATIENT HAD AN IRIS TUBE PLACED INTO THE LUNG RESULTING IN A PNEUMOTHORAX. THE RN REMOVED THE FEEDING TUBE AND TRIED TO PLACE THE TUBE AGAIN. THE PATIENT DIED FROM THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870497 10FR 43 IRIS FEEDING TUBE ENF TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH 461043E 20884521742199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death