BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC* J/TJ-16 INTRODUCER KIT

    MDR report key: 3961523 · Received July 28, 2014

    Report

    Report Number
    9611594-2014-00064
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    June 30, 2014
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KNT
    PMA / PMN Number
    PK080253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS 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 (B)(6).

    Description of Event or Problem · 1

    THIS IS THE FIRST OF TWO REPORTS INVOLVING TWO DEVICES USED DURING THE SAME PROCEDURE ON THE SAME PATIENT. REFER TO MFG. REPORT # 9611594-2014-00065 FOR THE SECOND REPORT. KIMBERLY-CLARK RECEIVED A REPORT STATING, "DR (B)(6)WAS PLACING THE T-FASTENERS AND 2 OF THE SUTURES BROKE WHEN HE WAS PULLING UP ON THEM. HE NEEDED TO USE AT LEAST 3 T-FASTENERS. THE SUTURES IN THE SECOND KIT ALSO BROKE. THERE WAS NO REPORTED PATIENT INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437920 MIC* J/TJ-16 INTRODUCER KIT ENTERAL FEEDING TUBE PLACEMENT KIT KNT KIMBERLY-CLARK HEALTH CARE 98435 ANP

    Patients

    Seq Age Sex Outcome Treatment
    1