BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    MDR report key: 19437403 · Received May 31, 2024

    Report

    Report Number
    2025851-2024-00004
    Event Type
    Injury
    Date Received
    May 31, 2024
    Date of Event
    April 22, 2024
    Report Date
    May 31, 2024
    Manufacturer
    XERIDIEM MEDICAL DEVICES
    Product Code
    PIF
    PMA / PMN Number
    K171347
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A6) NO PATIENT INFORMATION WAS AVAILABLE RELATED TO THIS EVENT. D4) MODEL NUMBER IS XERIDIEM PART NUMBER; CATALOG NUMBER IS PART NUMBER FOR EXCLUSIVE DISTRIBUTOR COOK MEDICAL THAT APPEARS ON THE LABEL. SINCE LOT NUMBER IS UNKNOWN, EXPIRATION DATE AND FULL UDI ARE UNKNOWN. H3) DEVICE HAS NOT BEEN RETURNED TO XERIDIEM FOR EVALUATION. H6) INVESTIGATION CODES CHOSEN BASED ON FOLLOWING SUMMARY OF THE INVISTIGATION: THE DEVICE WAS NOT RETURNED FOR EVALUATION SO INVESTIGATION WAS LIMITED TO REPORTED INFORMATION AND PART NUMBER TRENDING (5 BALLOON BURST COMPLAINTS IN PRIOR YEAR FOR THE ENTUIT PRODUCT FAMILY WITH JUST 1 BEING ON A 70-0060-116 DEVICE). BECAUSE OF THIS, ROOT CAUSE CANNOT BE ESTABLISHED. DURING MANUFACTURING, EACH DEVICE IS TESTED 100% INCLUDING A BALLOON INFLATION TEST. FACTORS THAT CAN AFFECT DEVICE PERFORMANCE INCLUDE DEVICE HANDLING, PACKAGING, SHIPPING, STORAGE, CLEANING AND MAINTENANCE. ADDITIONAL POSSIBILITIES THAT AFFECT BALLOON LIFE INCLUDE UNIQUE PATIENT FACTORS SUCH AS DIAGNOSIS, TREATMENT, SURGICAL PROCEDURES, AS WELL AS MEDICATIONS, NUTRITION FORMULAS, AND GASTRIC PH. PRODUCTION PERSONNEL ARE TRAINED AND CERTIFIED FOR MANUFACTURE OF THE DEVICES. TRENDING OF COMPLAINTS FOR THE DEVICE WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 0

    PATIENT EXPERIENCED TWO BALLOON RUPTURES OF THEIR GASTROSTOMY TUBE WITHIN A SHORT PERIOD. THE FIRST OCCURRED ON APRIL 18TH, WHEN THE BALLOON RUPTURED. THE TUBE WAS REPLACED. THE SECOND RUPTURE HAPPENED ON APRIL 22ND. THE PATIENT REPORTED ABDOMINAL PAIN, AND THE TUBE WAS FOUND DISLODGED AND RESTING ON HER ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400572 ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION GASTROSTOMY TUBE PIF XERIDIEM MEDICAL DEVICES 70-0060-116 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention