BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET

    MDR report key: 11448616 · Received March 9, 2021

    Report

    Report Number
    9611594-2021-00045
    Event Type
    Malfunction
    Date Received
    March 9, 2021
    Date of Event
    February 15, 2021
    Report Date
    April 2, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXACT LOT NUMBER INVOLVED IN THE EVENT IS UNKNOWN. A POTENTIAL LOT NUMBER WAS PROVIDED BY THE USER FACILITY AND THE DEVICE HISTORY RECORD FOR THAT LOT, LOT 2227488, WAS REVIEWED; THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. THE SAMPLE CONFIRMED THAT THE TUNGSTEN WEIGHTS CAME OUT OF THE TUBE; HOWEVER, THE ROOT CAUSE OF THE REPORTED ISSUE HAS NOT BEEN CONCLUSIVELY DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 02 APR 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 INC. 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 11-MAR-2021 INDICATED THE DEVICE WAS PLACED (B)(6) 2021 WITHOUT ANY IRREGULARITY. ON (B)(6) 2021, AN ENDOSCOPE WAS USED TO CHECK THE PATIENT FOR CHRONIC GASTRITIS AS BROWNISH MUCOSA WAS OBSERVED; HOWEVER, NO BLEEDING OR ANY IRREGULARITY OTHER THAN SLIGHT EROSION WAS FOUND. NO PATIENT INJURY HAS BEEN FOUND SINCE THE EVENT DATE. NO ABNORMAL SHAPE OF PLACED NG TUBE BY X-RAY. THE PATIENT WAS TAKING THE FOLLOWING MEDICATIONS: TRANSCEND, TAKECAB, MAGMITT, LANDSEN, FYCOMPA. THE HOSPITAL DOES NOT BELIEVE THE MEDICATIONS AFFECTED THE NG TUBE FUNCTIONALITY.

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. AN EXACT LOT NUMBER WAS NOT PROVIDED; HOWEVER, A POTENTIAL LOT NUMBER WAS RECEIVED AND A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 09 MAR 2021 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. 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)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NG [NASOGASTRIC] TUBE WAS DAMAGED AND TEN OF THE TWELVE TUNGSTEN WEIGHTS FROM THE TIP OF THE TUBE WERE RETAINED IN THE PATIENT. NO INTERVENTION HAS BEEN PERFORMED TO DATE, AND NO PATIENT INJURY WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343119 CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET DH CPK NG TUBES KNT AVANOS MEDICAL INC. 2227488 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1