BEUDAMED
    FDA Adverse Event Death Summary report: N

    MIC* BOLUS GASTROSTOMY FEEDING TUBE, 14 FR

    MDR report key: 3854043 · Received June 6, 2014

    Report

    Report Number
    9611594-2014-00041
    Event Type
    Death
    Date Received
    June 6, 2014
    Date of Event
    October 7, 2013
    Report Date
    May 31, 2014
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE UNABLE TO REVIEW THE DEVICE HISTORY RECORD AS NO LOT NUMBER WAS PROVIDED FOR THE DEVICE INVOLVED IN THIS REPORTED EVENT. THE DEVICE WAS NOT RETURNED TO KIMBERLY-CLARK FOR EVALUATION; THEREFORE, A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. KIMBERLY-CLARK IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION FROM THE UK REGARDING THIS REPORTED EVENT. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP REPORT CONTAINING THE ADDITIONAL INFORMATION WILL BE SUBMITTED. PERITONITIS IS AN ESTABLISHED RISK ASSOCIATED WITH GASTRIC FEEDING TUBES WITH AN IMPROBABLE (< 0.01/1000) OCCURRENCE. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS. DEVICE NOT RETURNED BY CUSTOMER.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT FROM THE (B)(6) STATING, ¿RADIOLOGICALLY INSERTED GASTROSTOMY (RIG) TUBE IMPLANTED (B)(6) 2013. TUBE DISPLACED (B)(6) 2013. IT IS SUSPECTED THAT THE BALLOON ON THE RIG DEVICE MAY HAVE FAILED, ALLOWING DISPLACEMENT OF THE DEVICE. PERITONITIS ENSUED AND SPITE CORRECT TREATMENT THE PATIENT DIED ON (B)(6) 2013." KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE AND IDENTIFIED AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331780 MIC* BOLUS GASTROSTOMY FEEDING TUBE, 14 FR ENTERAL FEEDING TUBE KNT KIMBERLY-CLARK HEALTH CARE 0110-14LV ANP

    Patients

    Seq Age Sex Outcome Treatment
    1 Death