BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE 3S LOW PROFILE BALLOON KIT

    MDR report key: 5359186 · Received January 11, 2016

    Report

    Report Number
    2025851-2016-00006
    Event Type
    Malfunction
    Date Received
    January 11, 2016
    Date of Event
    November 26, 2015
    Report Date
    December 8, 2015
    Manufacturer
    XERIDIEM MEDICAL DEVICES
    Product Code
    PIF
    PMA / PMN Number
    K142297
    Removal / Correction Number
    2025851-1/7/16-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION IS NOT AVAILABLE. XERIDIEM (LEGAL MANUFACTURER) PART NUMBER IS 70-0050-312; (B)(4) (EXCLUSIVE DISTRIBUTOR) PART NUMBER IS M00548240; THE (B)(4) PART NUMBER IS THE ONE APPEARING ON THE DEVICE LABEL. XERIDIEM IS LEGAL MANUFACTURER FOR THE DEVICE AND (B)(4) IS OUR EXCLUSIVE DISTRIBUTOR. THEREFORE THE INITIAL REPORTER TO XERIDIEM IS A PERSON ASSOCIATED WITH (B)(4). THE DEVICE WAS NOT ABLE TO BE RETURNED FOR EVALUATION SO A DEFINITE CAUSE FOR THE DEVICE INVOLVED FOR THIS REPORT COULD NOT BE DETERMINED. HOWEVER, A CAPA INVESTIGATION IS IN PROCESS FOR A TREND IN VALVE LEAKAGE. THIS INVISTIGATION IS IN PROCESS BUT APPEARS TO BE POINTING TOWARDS A DESIGN ISSUE WITH THE REFLUX VALVE (DOME VALVE). A RECALL ON THE (B)(4) DEVICES WAS INITIATED ON 12/23/2015. DEVICE WAS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    PLACE THE ENDOVIVE 3S BALLOON ON A SET OF TRIPLETS. AND LESS THAN 24 HOURS THEY WERE CALLING COMPLAINING WITH THE SAME CONCERN ABOUT LEAKAGE THAT THEY HAD PREVIOUSLY COMPLAINED. MOM WAS ABLE TO VIDEO PATIENT TO SHOW WHAT HAPPENED WHEN EXTENSION IS REMOVED AFTER FEED. ALL THE FORMULA LITERALLY SPREAD OUT AND LOOKS LIKE A SPRINKLER IS ON. MOM HAD TO DISCONTINUE USE OF BUTTONS DUE TO THE AMOUNT OF FORMULA THAT WAS LOST. DEVICE 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17099 ENDOVIVE 3S LOW PROFILE BALLOON KIT LOW PROFILE BALLOON GASTROSTOMY TUBE PIF XERIDIEM MEDICAL DEVICES 70-0050-312 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1