BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10FR 43 IRIS FEEDING TUBE ENF

    MDR report key: 9772011 · Received February 28, 2020

    Report

    Report Number
    1282497-2020-08945
    Event Type
    Malfunction
    Date Received
    February 28, 2020
    Date of Event
    February 22, 2020
    Report Date
    April 23, 2020
    Manufacturer
    COVIDIEN
    Product Code
    PIF
    UDI-DI
    20884521706122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE A LOT NUMBER WAS NOT PROVIDED, THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. NO SAMPLE HAS BEEN RETURNED FOR THE INVESTIGATION. A PHOTO WAS PROVIDED FOR THE ANALYSIS. THE SUPPLIER HAS REVIEWED THEIR MANUFACTURING PROCESS. THE FEEDING PORT IS PROCURED FROM THE CARDINAL HEALTH SUPPLIER. THE PORT IS THE ASSEMBLY TO THE FEEDING TUBE WITH GLUE, NO FOREIGN FORCE IS APPLIED TO THE PORT DURING THE ASSEMBLY PROCESS. ALL THE TUBES ARE INSPECTED BY FNI (FINAL INSPECTION), BROKEN PORT CAN BE 100% DETECTED BEFORE PACKAGING. FROM THE INVESTIGATION, SUPPLIER WAS UNABLE TO DETERMINE THE DEFINITIVE ROOT CAUSE DUE TO LIMITED INFORMATION PROVIDED. A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MAIN ENFIT FEEDING PORT ON THE KANGAROO IRIS FEEDING TUBE BROKE; THE THREADED PART OF THE PORT DETACHED OFF THE TUBE. THE TUBE HAD TO BE REMOVED DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234400 10FR 43 IRIS FEEDING TUBE ENF GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF COVIDIEN 461043E 20884521706122

    Patients

    Seq Age Sex Outcome Treatment
    1