BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET

    MDR report key: 10829800 · Received November 12, 2020

    Report

    Report Number
    9611594-2020-00218
    Event Type
    Injury
    Date Received
    November 12, 2020
    Date of Event
    October 17, 2020
    Report Date
    January 12, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770457857
    PMA / PMN Number
    K821906
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR LOT 30033022 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ONE USED SAMPLE WAS RETURNED FOR EVALUATION. THE SAMPLE WAS INFUSED WITH WATER AND A TEAR/HOLE WAS IDENTIFIED WHICH CAUSED THE TUBE TO LEAK. INSPECTION UNDER MAGNIFICATION REVEALED DENT MARKS AROUND THE AREA OF THE HOLE. THE AREA WHERE THE UNEVEN SURFACE APPEARED JAGGED AND/OR WRINKLED. THE TUBING WAS CUT TO VIEW THE INSIDE SURFACE OF THE TUBING. ONCE THE TUBING WAS OPENED, THERE WERE LINES, INDENTATIONS AND LOOSE PARTICLES IN THE INNER WALLS OF THE TUBING. THE COMPLAINT IS CONFIRMED AS REPORTED, HOWEVER, NO DEFINITE ROOT CAUSE COULD BE DETERMINED. A REVIEW OF THE MANUFACTURING PROCESS DID NOT REVEAL ANY ACTIVITIES OR TOOLS THAT COULD CAUSE THE DAMAGE OBSERVED. PER THE INSTRUCTIONS FOR USE FOR THE DEVICE, VIGOROUS SYRINGE FORCE SHOULD NOT BE USED TO IRRIGATE, ADMINISTER LIQUIDS, OR UNBLOCK THE TUBE. ALL INFORMATION REASONABLY KNOWN AS OF 11 JAN 2021 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 AVANOS MEDICAL 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

    (B)(4). THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 11 NOV 2020 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 AVANOS MEDICAL COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS NOTED AT 10PM THAT THERE WAS MILK COMING OUT FROM NEAR THE HUB OF THE FEEDING TUBE. THE PATIENT WAS RECEIVING SERUM GLUCOSE AT 50MG/DL ON CONTINUOUS ORAL DIGESTIVE TUBE (ODT) FEEDING, 12ML/HOUR. THE PATIENT'S SERUM GLUCOSE WAS "AT 30'S AT START OF SHIFT DUE TO ODT NEEDED TO BE REINSERTED AND VERIFIED BY X-RAY" AT 7PM. PATIENT HAS HISTORY OF HYPOGLYCEMIA. DUE TO THE LEAK, A NEW TUBE WAS ATTEMPTED TO BE INSERTED BY A NEONATAL NURSE PRACTITIONER (NNP), TWICE, UNSUCCESSFULLY. INSTEAD THE TUBE WAS PLACE NASOGASTRICALLY (NGT), AND PLACEMENT WAS CONFIRMED WITH X-RAY. SERUM GLUCOSE WAS THEN MONITORED EVERY 15 MINS, EVERY 30 MINS THEN HOURLY X2 UNTIL STABLE. SERUM GLUCOSE STABILIZED WHEN NGT FEEDING RESUMED. PER ADDITIONAL INFORMATION RECEIVED 5 NOV 2020, THE ODT HAD BEEN IN PLACE FOR 1 3/4 HOURS PRIOR TO THE FEEDING TUBE LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294787 CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET DH CPK NG TUBES KNT AVANOS MEDICAL INC. 20-9366 30033022 00350770457857

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Other