BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC JEJUNAL FEEDING TUBE, 12 FR

    MDR report key: 3802871 · Received May 9, 2014

    Report

    Report Number
    9611594-2014-00038
    Event Type
    Injury
    Date Received
    May 9, 2014
    Report Date
    April 16, 2014
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 WE ARE UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED EVENT. 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 STATING, "WHEN PHYSICIAN WAS PLACING THIS TUBE, THE DISTAL END PERFORATED THE PATIENT'S BOWEL. TUBE WAS INITIAL PLACED ON (B)(6) 2014. PATIENT'S CONDITION WAS BEING MONITORED AND WAS DETERIORATING FROM BASELINE. PATIENT WAS TAKEN TO SURGERY ON (B)(6) 2014 FOR EXPLORATORY LAPARATOMY. SURGERY REVEALED THE J-TUBE HAD ERODED IN THE PATIENT'S BOWEL AND TUBE FEED HAD LEAKED INTO THE PERITONEAL CAVITY. THE TUBE WAS REMOVED AND THE PATIENT WAS TREATED FOR PERITONITIS. THE PHYSICIAN CONCLUDED THE TISSUE SURROUNDING THE ERODED AREA WAS HEALTHY AND DID NOT REQUIRE ANY FURTHER TREATMENT.¿ 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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280348 MIC JEJUNAL FEEDING TUBE, 12 FR ENTERAL FEEDING TUBE KNT KIMBERLY-CLARK HEALTH CARE 0200-12LV ANP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization