BEUDAMED
    FDA Adverse Event Summary report: N

    MIC G-18 INTRODUCER KIT

    MDR report key: 3982334 · Received August 5, 2014

    Report

    Report Number
    9611594-2014-00067
    Date Received
    August 5, 2014
    Report Date
    July 7, 2014
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KGC
    PMA / PMN Number
    PK080253
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

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

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, A INTERVENTIONAL RADIOLOGIST PHYSICIAN PHONED TODAY TO SAY THAT BECAUSE HE DID NOT PROPERLY USE THE SERIAL DILATOR AND PEEL AWAY SHEATH IN OUR INITIAL PLACEMENT KIT (IPK), THE TUBE WAS NOT PLACED IN THE GASTRIC LUMEN. HE STATES THAT THE PATIENT WAS OK, BUT THAT HE MADE A MISTAKE. PATIENT WAS TAKEN TO THE OPERATING ROOM FOR A LAPAROSCOPIC PROCEDURE TO REPLACE THE TUBE HE PLACED. NO PATIENT INJURY, THE PATIENT IS STILL DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458067 MIC G-18 INTRODUCER KIT ENTERAL FEEDING TUBE PLACEMENT KIT KGC KIMBERLY-CLARK HEALTH CARE UNKNOWN ANP

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other