BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    MDR report key: 7466580 · Received April 26, 2018

    Report

    Report Number
    2025851-2018-00010
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Date of Event
    March 2, 2018
    Report Date
    April 30, 2018
    Manufacturer
    XERIDIEM MEDICAL DEVICES
    Product Code
    PIF
    PMA / PMN Number
    K130611/A001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT ADDS THREE ADDITIONAL COMPLAINT REPORTS THAT ARE FROM THE SAME HEALTHCARE FACILITY, ON THE SAME DEVICE CATALOG NUMBER, AND FOR THE SAME ISSUE AS THE ORIGINAL MDR. DATE ENTERED IS FOR THE FIRST ADDITIONAL REPORT. THE OTHER TWO ADDITIONAL REPORTS WERE RECEIVED ON MAY 21, 2018 AND JUNE 29, 2018. PRODUCT WAS RETURNED ON THE FIRST ADDITIONAL REPORT AND THE ENFIT CONNECTOR CRACKING FAILURE WAS CONFIRMED WITH NO NEW FINDING AS COMPARED TO THE ORIGINAL MDR. AS STATED IN THE ORIGINAL MDR, XERIDIEM IS CURRENTLY WORKING THROUGH PRODUCTION IMPLEMENTATION OF THE CHANGE (ENFIT CONNECTOR MATERIAL) THAT CORRECTS THIS PROBLEM.

    Description of Event or Problem · 0

    SAME AS ORIGINAL REPORT 2025851-2018-00010.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION IS AVAILABLE. EVENT DATE IS ESTIMATED BASED UPON REPORT DATE (EVENT DATE MAY BE EARLIER). THIS MDR GROUPS FOUR COMPLAINTS WHICH ARE ON THE SAME MODEL NUMBER AND FOR THE SAME ISSUE. ENTERED DATE IS EARLIEST OF THE FOUR. THE REMAINING THREE WERE REPORTED ON (B)(6) 2018, (B)(6) 2018 AND (B)(6) 2018. MODEL NUMBER IS XERIDIEM PART NUMBER. CATALOG NUMBER IS PART NUMBER FOR COOK MEDICAL, XERIDIEM'S EXCLUSIVE DISTRIBUTOR FOR THIS DEVICE. SINCE LOT NUMBER IS UNKNOWN, EXPIRATION DATE AND FULL UDI ARE NOT KNOWN. IMPLANT/EXPLANT DATES ARE NOT KNOWN. DEVICES HAVE NOT BEEN RETURNED ON THIS GROUP OF FOUR COMPLAINTS (ALTHOUGH A RETURN ON THE 3/30/2018 COMPLAINT COULD STILL BE POSSIBLE). HOWEVER, THE REPORTED ISSUE IS A KNOWN ONE. A FOLLOW-UP REPORT WILL ONLY BE PROVIDED IF THE DEVICE IS RETURNED ON THE FOURTH COMPLAINT AND LEADS TO A DIFFERENT FINDING FROM THE KNOWN ISSUE. (B)(6). DEVICE RETURN DATE LISTED IS FOR FIRST OF THE 4 COMPLAINTS. THE OTHER THREE WERE REPORTED ON 3/12/2018, 3/19/2018 AND 3/30/2018. DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION ON THIS GROUP OF COMPLAINTS (ALTHOUGH A RETURN COULD STILL BE POSSIBLE ON THE 3/30/2018 COMPLAINT). HOWEVER, THE ISSUE IS KNOWN. DATE OF MANUFACTURE CANNOT BE DETERMINED SINCE LOT NUMBER IS UNKNOWN. KNOWN ISSUE WHICH IS RESOLVED BY CHANGE RECENTLY CLEARED IN K171347. XERIDIEM IS PREENTLY WORKING THROUGH PRODUCTION IMPLEMENTATION OF THIS CHANGE.

    Description of Event or Problem · 1

    THE ENFIT CAPS AND FEEDING PORT CONNECTIONS ARE BREAKING. THERE ARE SMALL CRACKS IN THE CAPS THEMSELVES AND THE THREADED FLANGES ARE BREAKING OFF. THE PATIENT IS ALSO USING TOOLS TO GET CAPS UNSTUCK. THE CAPS NEED TO BE TIGHTENED DOWN HARD OR ELSE THEY LEAK. THE ENFIT THAT IS GLUED INTO TUBE IS BREAKING WHEN PATIENTS TRY TO WIGGLE THE ENFIT CONNECTION OUT OF THE FEEDING PORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308196 ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION GASTROSTOMY TUBE PIF XERIDIEM MEDICAL DEVICES 70-0060-222 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1