BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR

    MDR report key: 7923858 · Received October 1, 2018

    Report

    Report Number
    9611594-2018-00156
    Event Type
    Malfunction
    Date Received
    October 1, 2018
    Date of Event
    September 9, 2018
    Report Date
    November 12, 2018
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    20815149020666
    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

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR LOT 0202825895 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 09 NOV 2018 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 · 0

    ONE USED SAMPLE WAS RETURNED FOR EVALUATION. THE SAMPLE WAS RECEIVED IN TWO PIECES. THE TUBING WAS EXAMINED AND FOUND TO HAVE SIGNS OF DAMAGE. A SPLIT/TEAR WAS IDENTIFIED BETWEEN 51-50CM MARKING. IN THIS AREA, THE TUBING APPEARED TO HAVE EXPANDED TO FORM A BALLOON SHAPE, WHICH THEN BURST AXIALLY CAUSING A SEPARATION OF THE TUBE. THE BREAK POINTS WERE VIEWED UNDER 50X MAGNIFICATION. THE DISTAL END SIDE EXHIBITED A LARGE AMOUNT OF DRIED FOREIGN MATERIAL BUILD UP INSIDE THE TUBING. THE COMPLAINT IS CONFIRMED. NO ROOT CAUSE WAS IDENTIFIED. HOWEVER, PER THE INSTRUCTIONS FOR USE WHICH ACCOMPANY THE DEVICE, VIGOROUS SYRINGE FORCE SHOULD NOT BE USED TO IRRIGATE, ADMINISTER LIQUIDS, OR UNBLOCK THE TUBE. ALL INFORMATION REASONABLY KNOWN AS OF 15 NOV 2018 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 SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 25 SEP 2018 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 A AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON REMOVAL OF THE NASO-JEJUNAL (NJ) TUBE FROM A PATIENT IN PEDIATRIC INTENSIVE CARE, IT WAS NOTICED THAT THE TUBE HAD BROKEN, AND PART OF THE TUBE REMAINED INSIDE THE PATIENT. A PROCEDURE WAS PERFORMED TO REMOVE THE BROKEN PIECE OF TUBE, AND TO RE-PASS A NEW NJ TUBE. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762766 CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR DH CPK NG TUBES KNT AVANOS MEDICAL INC. 42-9366 0202825895 20815149020666

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO