BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NG/NI FT W/ STYLET & ENFIT

    MDR report key: 16040068 · Received December 22, 2022

    Report

    Report Number
    9611594-2022-00159
    Event Type
    Malfunction
    Date Received
    December 22, 2022
    Date of Event
    November 8, 2022
    Report Date
    February 8, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460505
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR LOT 30208011WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 17 JAN 2023 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 · 0

    THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 22 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. 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 · 0

    THE ACTUAL SAMPLE FROM THE REPORTED EVENT WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION OF THE DEVICE REVEALED THE TUBING HAD SIGNS OF DAMAGE AND DISCOLORATION. TESTING OF THE SAMPLE: WHEN THE TUBING WAS MANUALLY PRESSED BACK TOGETHER, THIN LAYERS OF THE MATERIAL WERE NOTICED ON THE BALLOONED PORTION OF THE TUBE AND BOTH BREAKING POINTS EXHIBITED UNKNOWN BUILD-UP RESIDUES. THE REPORTED EVENT COULD BE CONFIRMED AS REPORTED: THE TUBE EXPANDED TO FORM A BALLOON SHAPE WHICH BURST AND CAUSED A SEPARATION OF THE TUBE. THE ROOT CAUSE IS UNDETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 08 FEB 2023 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

    ADDITIONAL INFORMATION RECEIVED 22DEC2022 REPORTED, THE TUBE WAS PLACED ON (B)(6) 2022 AND WAS REMOVED ON (B)(6) 2022; THE TUBE INTEGRITY WAS NOTICED ON AN X-RAY. THE SYRINGE SIZE USED FOR SMALL CHILDREN WAS NO MORE THAN 10MLS; ALL OF THE MEDS WERE LIQUID.

    Description of Event or Problem · 0

    FDA MEDWATCH / FDA USER FACILITY REPORT # MW (B)(4). REPORTED, THE INFANT WAS INTUBATED. A CHEST X-RAY WAS USED REVEALED DILATATION/BALLOONING AT THE CERVICAL PORTION OF THE CORFLO NASOGASTRIC/NASOINTESTINAL (NG) FEEDING TUBE. A SECOND X-RAY WAS COMPLETED WHICH SHOWED FOCAL DISCONTINUITY OF THE CORFLO TUBE AT THE LEVEL OF THE THORACIC INLET. THE NG TUBE WAS REMOVED IN ITS ENTIRETY SHOWING AN ANEURYSMAL SECTION WITH LUMEN EXPOSED. IT WAS ADDITIONALLY REPORTED, THE NG TUBE WAS BEING USED FOR TUBE FEED; HOWEVER, ¿THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.¿ THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2108659 CORFLO NG/NI FT W/ STYLET & ENFIT DH CPK NG TUBES KNT AVANOS MEDICAL INC. 40-9438 30208011 00350770460505

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Male