BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    MDR report key: 7441807 · Received April 18, 2018

    Report

    Report Number
    2025851-2018-00004
    Event Type
    Injury
    Date Received
    April 18, 2018
    Report Date
    March 30, 2018
    Manufacturer
    XERIDIEM MEDICAL DEVICES
    Product Code
    PIF
    UDI-DI
    00827002447837
    PMA / PMN Number
    K130611/A01
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRECISE EVENT DATE IS NOT KNOWN. MODEL NUMBER IS XERIDIEM PART NUMBER. CATALOG NUMBER IS PART NUMBER FOR XERIDIEM'S EXCLUSIVE DISTRIBUTOR FOR THE DEVICE, COOK MEDICAL. PRECISE IMPLANT/EXPLANT DATES ARE NOT AVAILABLE. USER FACILITY (B)(6) FILED MEDWATCH REPORT MW6076060. CODE CHOSEN FOR CONCLUSION REPRESENTS THE KNOWN ISSUE EVEN WITH NO DEVICE RETURNED. THE ISSUE IS RESOLVED WITH THE CHANGE RECENTLY CLEARED IN K171347. XERIDIEM IS PRESENTLY WORKING THROUGH PRODUCTION IMPLEMENTATION OF THIS CHANGE.

    Description of Event or Problem · 1

    OVER THE PAST SEVERAL WEEKS, (B)(6) HAS HAD NUMEROUS PATIENTS WITH ENTUIT GASTROSTOMY TUBE RETURN TO OUR FACILITY DUE TO THE "ENFIT" CAPS BREAKING ON THE TUBES THAT WERE PLACED. THIS DEFECT PRESENTS A DELAY IN PATIENT CARE, AS WELL AS A POTENTIAL RISK FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282974 ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION GASTOSTOMY TUBE PIF XERIDIEM MEDICAL DEVICES 70-0060-118 953602 00827002447837

    Patients

    Seq Age Sex Outcome Treatment
    1