BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR

    MDR report key: 14794723 · Received June 23, 2022

    Report

    Report Number
    9611594-2022-00085
    Event Type
    Malfunction
    Date Received
    June 23, 2022
    Date of Event
    May 18, 2022
    Report Date
    June 23, 2022
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770460802
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE DEVICE WAS RECEIVED AND EVALUATED. THE RECEIVED SAMPLE WAS NOT RETURNED WITH THE ORIGINAL PACKAGING. NO OTHER COMPONENT WAS RECEIVED. DURING CLEANING AND DECONTAMINATION THE TUBE WAS ALSO FLUSHED THROUGH FROM THE AREA OF SEPARATION (22CM MARKING). RESISTANCE WAS FELT WHILE FLUSHING AND THE TRAPPED SUBSTANCES/ MATERIALS WERE FLUSHED OUT OF THE TUBE AFTER COUPLE ATTEMPTS. SINCE THE TUBE WAS RECEIVED PARTIALLY, NO PROXIMAL END, THE BREAKING POINT OF THE DISTAL END STARTING AT THE 22CM WAS EXAMINED UNDER MAGNIFICATION (20X). THERE WERE THIN LAYERS TO THE TUBING MATERIAL THAT INITIALLY EXPANDED AND BURST INTO TWO PIECES. (ONE PIECE WAS ONLY RETURNED IN THE LAB) THE BURST WAS LOCATED BETWEEN 21-22CM MARKING. THERE WAS NO DRIED FOREIGN MATERIAL RESIDUE SEEN AT THE DISTAL END BREAKING POINT. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 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, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(6). 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

    IT WAS REPORTED THE DISTAL PART OF THE FEEDING TUBE HAD SEPARATED FROM THE REST OF THE TUBE DUE TO A BREAK IN THE TUBE. THE PROXIMAL PART OF THE TUBE WAS REMOVED FROM THE PATIENT, BUT THE PART THAT WAS SEPARATED REMAINED INSIDE OF THE PATIENT, AND HAD TO BE REMOVED BY ENDOSCOPY. THE USER NOTED "TO ME IT LOOKS LIKE THE TUBE HAS BURST WHERE EXCESSIVE PRESSURE HAS BEEN EXERTED PRESUMABLY TO TRY AND CLEAR A BLOCKAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328762 CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR DH CPK NG TUBES KNT AVANOS MEDICAL INC. 42-7361 UNKNOWN 00350770460802

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male