BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24 FR SERIAL DILATOR

    MDR report key: 5020153 · Received August 20, 2015

    Report

    Report Number
    9611594-2015-00143
    Event Type
    Malfunction
    Date Received
    August 20, 2015
    Date of Event
    April 22, 2015
    Report Date
    July 24, 2015
    Manufacturer
    HALYARD HEALTH
    Product Code
    KGC
    PMA / PMN Number
    PK093312
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, AA4307R11, WAS REVIEWED AND DOCUMENTED THAT THE LOT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MEDWATCH REPORT, REFERENCE NUMBER (B)(4), THAT A SURGICAL PROCEDURE WAS REQUIRED TO PLACE A MIC-KEY GASTRONOMY ENTERAL FEEDING TUBE FOR A PATIENT WITH AN EXISTING STOMA. WHEN REMOVING THE DILATOR THE 8-FR PORTION OF THE DEVICE CAME OUT OF THE SHEATH. THE DISTAL PORTION REMAINED IN THE PATIENT'S STOMACH. UNSUCCESSFUL ATTEMPTS WERE MADE TO REMOVE THE DISTAL PORTION OF THE DILATOR FROM THE PATIENT AND SURGERY WAS REQUIRED TO REMOVE THE DISTAL PORTION OF THE DILATOR FROM THE PATIENT'S STOMACH AND A JEJUNAL ENTERAL FEEDING TUBE WAS SURGICALLY PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553253 24 FR SERIAL DILATOR ENTERAL FEEDING PLACEMENT KIT KGC HALYARD HEALTH 98706 AA4307R11

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention