BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC* TJ FEEDING TUBE KIT 18 FR, 45CM (SURGICAL)

    MDR report key: 4212216 · Received October 30, 2014

    Report

    Report Number
    9611594-2014-00146
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Report Date
    October 1, 2014
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KNT
    PMA / PMN Number
    PK043114
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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). DEVICE NOT RETURNED BY CUSTOMER.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A MEDWATCH REPORT STATING THE PATIENT HAD A MIC TRANSGASTRIC GASTROJEJUNAL FEEDING TUBE PLACED ABOUT FOUR YEARS AGO. THE PATIENT HAS HAD SIX REPLACEMENT TUBES SINCE THEN DUE TO MALFUNCTION OF THE TUBE. THE LAST REPLACEMENT TUBE WAS APPROXIMATELY A FEW WEEKS AGO. THE PHYSICIAN REPORTS THAT THE TUBES ARE BREAKING DOWN EARLIER THAN EXPECTED AND CAN RESULT IN LEAKING. THE ENTERAL FEEDING TUBES HAVE LAST FROM FOUR TO ELEVEN MONTHS AND THEN REQUIRE REPLACEMENT. THE MIC TRANSGASTRIC GASTROJEJUNAL FEEDING TUBES REQUIRED ENDOSCOPIC REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED IN REGARDS TO THE PATIENT'S STATUS AND THE OUTCOME OF THE PROCEDURE. THIS IS THE THIRD OF SIX REPORTS FOR THE SAME PATIENT INVOLVING SIX SEPARATE PRODUCTS. REFER TO REPORT 9611594-2014-00145 FOR THE SECOND REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695088 MIC* TJ FEEDING TUBE KIT 18 FR, 45CM (SURGICAL) ENTERAL FEEDING TUBE KNT KIMBERLY-CLARK HEALTH CARE 0260-18

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization