BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC GASTROSTOMY FEEDING TUBE

    MDR report key: 4060393 · Received September 4, 2014

    Report

    Report Number
    9611594-2014-00094
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    July 30, 2014
    Report Date
    August 5, 2014
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KNT
    PMA / PMN Number
    PK993138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. 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 COMPLAINT (B)(4).

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING THE PATIENT ORIGINALLY HAD A MIC-J TUBE PLACED IN (B)(6) 2014 AND THE DEVICE REMAINED IN USE UNTIL (B)(6) 2014. THE TUBE PORT CRACKED FROM THE PORT SITE DOWN TO THE BALLOON, THE PART THAT CONNECTS TO THE EXTENSION SET BROKE APART INTO PIECES. THIS CAUSED FEEDING AND BILE TO LEAK OUT ALL OVER THE PATIENT. THE STOMA WAS KEPT OPEN BY USING A GASTROSTOMY TUBE THE MOM HAD ON HAND. THE PATIENT WAS TAKEN TO THE HOSPITAL AND ADMITTED FOR THREE TO FOUR DAYS AT THAT TIME. WHILE IN THE HOSPITAL THE PATIENT'S DIAGNOSIS CODE DURING HOSPITALIZATION WAS "FAULTY EQUIPMENT". ANOTHER GASTROSTOMY TUBE WAS PLACED IN (B)(6) 2014. ON (B)(6) 2014 THE TUBE PORT CRACKED. THE PATIENT WAS ADMITTED INTO THE HOSPITAL FOR TUBE REINSERTION. THE PATIENT STAYED IN THE HOSPITAL FOR ONE DAY. THE PATIENT'S MOM IS CONCERNED BECAUSE THE PATIENT HAS COMPLEX MEDICAL NEEDS THAT REQUIRE 24-HOUR CONTINUOUS FEEDING WITH MULTIPLE DAILY MEDICATIONS AND HAD TO BE ADMITTED TO HOSPITAL ON TWO OCCASIONS. ON BOTH HOSPITAL ADMISSIONS THE PATIENT REQUIRED SEDATION TO HAVE THE FEEDING TUBE REINSERTED, AND PATIENT DOES NOT TOLERATE SEDATION. THE FIRST EVENT FOR THIS COMPLAINT IS REFERENCED IN MDR 9611594 -2014-00093.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541813 MIC GASTROSTOMY FEEDING TUBE ENTERAL FEEDING TUBE KNT KIMBERLY-CLARK HEALTH CARE UNKNOWN ANP

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization