BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNEC

    MDR report key: 8332217 · Received February 12, 2019

    Report

    Report Number
    9611594-2019-00024
    Event Type
    Malfunction
    Date Received
    February 12, 2019
    Report Date
    February 12, 2019
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE USED DEVICE WAS RECEIVED FOR EVALUATION. IT WAS NOT POSSIBLE TO FLUSH FLUID THROUGH THE DEVICE DUE TO A BLOCKAGE IN THE TUBING, BUT DRIED MATTER IN THE FEED PORTS WAS DISLODGED DURING THE DECONTAMINATION PROCESS. THE TUBING HAD GRADUATED BROWN DISCOLORATION, STARTING AS LIGHT BROWN AROUND THE 60CM MARK AND BECOMING DARKER AS IT EXTENDS DISTALLY. THE TUBING EXHIBITED BALLOONING AND A COMPLETE RUPTURE AT APPROXIMATELY THE 41CM DEPTH MARK. IN THE DARKER DISCOLORED SECTION OF TUBING, PROXIMAL TO THE RUPTURE THERE WAS A TOTAL OCCLUSION OF THE TUBE. THE RUPTURED END WAS EXAMINED UNDER MAGNIFICATION. SOME DRIED MATTER WAS OBSERVED JUST INSIDE THE TUBE. PROXIMAL TO THE RUPTURE, THE TUBING WAS FOUND TO BE FIRM WHEN PRESSED, INDICATING THE PRESENCE OF AN OCCLUSION. THE COMPLAINT IS CONFIRMED, AS THE TUBING EXHIBITED BALLOONING WITH RUPTURE. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER; THIS SEEMS TO BE A USER RELATED PROBLEM SINCE AS PER THE INSTRUCTIONS FOR USE, VIGOROUS SYRINGE FORCE SHOULD NOT BE USED TO IRRIGATE, ADMINISTER LIQUIDS, OR UNBLOCK THE TUBE. ALL INFORMATION REASONABLY KNOWN AS OF 28 FEB 2019 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL INC. AVANOS MEDICAL INC. 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 HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 11 FEB 2019 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. AVANOS MEDICAL INC. 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 HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBE LOOKED ERODED AND HAD BROKEN OFF. THE PATIENT DID NOT REPORT TO THE REPORTER THAT THE TUBE PIECE HAD PASSED IN THEIR BOWEL MOVEMENT. THE TUBE HAD BECOME KINKED OR BLOCKED AND WAS REMOVED VIA ENDOSCOPY. THE EROSION WAS DISCOVERED AFTER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126219 CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNEC DH CORTRAK DISPOSABLES KNT AVANOS MEDICAL INC. 42-9558 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1