BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR

    MDR report key: 15638360 · Received October 20, 2022

    Report

    Report Number
    9611594-2022-00132
    Event Type
    Malfunction
    Date Received
    October 20, 2022
    Date of Event
    October 5, 2022
    Report Date
    December 22, 2022
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460925
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS REPORTED AVAILABLE BUT NOT YET RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 18 OCT 2022 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED IF ADDITIONAL INFORMATION IS OBTAINED. 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 REPORTED EVENT BUT IS RELAYING THE INFORMATION 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 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. 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

    THE DEVICE HISTORY RECORD FOR LOT 30113511 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS AND A ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 20 DEC 2022 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 REPORTED EVENT BUT IS RELAYING THE INFORMATION 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 · 0

    THE ACTUAL SAMPLE FROM THE REPORTED EVENT WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION OF THE DEVICE REVEALED THAT THE TUBING HAD SIGNS OF DAMAGE, DISCOLORATION, AND BUILD-UP. THE TUBE WAS FLUSHED THROUGH THE Y-CONNECTOR (PROXIMAL END). RESISTANCE WAS FELT WHILE FLUSHING AND SUBSTANCES WERE UNABLE TO FLUSH OUT OF THE TUBE AFTER A COUPLE OF ATTEMPTS. TESTING OF THE SAMPLE REVEALED THAT THERE WAS A SPLIT/TEAR IDENTIFIED APPROXIMATELY AT THE 24-CENTIMETER (CM) MARKING. THE LIGHT BROWNISH DISCOLORATION STARTED ON 32CM MARKING UNTIL THE BOLUS TIP (DISTAL END) OF THE TUBE. AT THE 24CM MARKED LOCATION, THE TUBING APPEARED TO HAVE EXPANDED TO FORM A BALLOON SHAPE WHICH BURST IN MULTIPLE DIRECTIONS CAUSING A SEPARATION OF THE TUBE INTO TWO PIECES. WHEN MANUALLY PRESSING THE TUBING BACK TOGETHER, THERE WERE THIN LAYERS OF THE MATERIAL NOTICED ON THE BALLOONED PORTION OF THE TUBE. BOTH BREAKING POINTS EXHIBITED UNKNOWN DRIED FOREIGN MATERIAL RESIDUE. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 10 NOV 2022 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.

    Description of Event or Problem · 0

    AVANOS MEDICAL INC. RECEIVED A REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH TWO SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2022-00131 FOR THE FIRST REPORT. IT WAS REPORTED THAT AFTER 4 WEEKS OF USE, THE RADIOLOGIC-INSERTED NASOJEJUNAL FEEDING TUBE SPLIT, ALLOWING FEED TO BE DELIVERED INTO THE STOMACH SEEN BY X-RAY. NO INJURY OR MEDICAL INTERVENTIONS REPORTED. THE PROBLEM WAS NOTICED BY ROUTINE X-RAY, WHICH SHOWED BALLOONING IN THE OESOPHAGUS LIKE THE LAYERS OF TUBE HAVE SEPARATED. THE PHARMACIST IS TO REVIEW MEDICATIONS IN CASE THAT CAUSED A BLOCKAGE AND BALLOONING. THE CHILD HAS NO ISSUES WITH TUBE PROBLEM. IT WAS SPOTTED ON ROUTINE X-RAY.

    Description of Event or Problem · 0

    THE INITIAL INFORMATION WAS RECEIVED BY AVANOS ON 06OCT2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121291 CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR DH CPK NG TUBES KNT AVANOS MEDICAL INC. UNKNOWN 30113511 00350770460925
    2002680 CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR DH CPK NG TUBES KNT AVANOS MEDICAL INC. UNKNOWN 30113511 00350770460925

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown