BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE STANDARD BALLOON BALLOON REPLACEMENT KIT, STRAIGHT BOLSTER

    MDR report key: 5927033 · Received September 2, 2016

    Report

    Report Number
    2025851-2016-00014
    Event Type
    Malfunction
    Date Received
    September 2, 2016
    Date of Event
    June 19, 2016
    Report Date
    August 5, 2016
    Manufacturer
    XERIDIEM MEDICAL DEVICES
    Product Code
    KNT
    PMA / PMN Number
    K083684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    XERIDIEM (LEGAL MANUFACTURER) PART NUMBER IS 70-0024-022; (B)(4) (EXCLUSIVE DISTRIBUTOR) PART NUMBER IS M00582860; THE (B)(4) PART NUMBER IS THE ONE APPEARING ON THE DEVICE LABEL; ALSO, UDI COMPLIANT LABELING WAS NOT YET APPLICABLE AT THE TIME OF MANUFACTURE OF THIS PARTICULAR DEVICE. USER REPORT MW5063575 INDICATED YES ON DEVICE AVAILABILITY. IT APPEARS THAT THE DEVICE WAS NOT RETURNED TO (B)(4) AND IS UNLIKELY TO STILL BE AVAILABLE FOR EVALUATION. AS NOTED ABOVE, THE DEVICE WAS NOT RETURNED FOR EVALUATION. SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, A DEFINITE ROOT CAUSE FOR DEVICE FAILURE COULD NOT BE DETERMINED. HOWEVER, THE DEVICE HISTORY RECORD FOR THE LOT WAS REVIEWED AND THERE WERE NO IN PROCESS NON-CONFORMANCES THAT HAD TO BE RESOLVED BEFORE SHIPPING THIS LOT. ALL REQUIREMENTS WERE MET. DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    PATIENT WENT TO SURGERY FOR OPEN FEEDING G-TUBE PLACEMENT AND OPEN TRACHEOSTOMY. A 22 FRENCH STANDARD BALLOON REPLACEMENT KIT WAS USED FOR G-TUBE PLACEMENT IN THE STOMACH. SUBSEQUENT TO PLACEMENT, THE G-TUBE HAD FALLEN OUT AND APPEARED TO HAVE A DEFECT CAUSING THE BALLOON TO DEFLATE OVER SEVERAL HOURS, ALLOWING THE G-TUBE TO FALL OUT SPONTANEOUSLY. PATIENT RETURNED TO SURGERY FOR REPLACEMENT OF THE G-TUBE WITH A 22 FRENCH STANDARD BALLOON REPLACEMENT. XERIDIEM RECEIVED THIS INFORMATION FROM VOLUNTARY EVENT REPORT MW5063575 (MEDWATCH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576325 ENDOVIVE STANDARD BALLOON BALLOON REPLACEMENT KIT, STRAIGHT BOLSTER GASTROSTOMY TUBE KNT XERIDIEM MEDICAL DEVICES 70-0024-022 911504

    Patients

    Seq Age Sex Outcome Treatment
    1