BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN (NEOMED AND NEOCONNECT) NASOGASTRIC TUBE

    MDR report key: 11681960 · Received April 16, 2021

    Report

    Report Number
    9611594-2021-00058
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Report Date
    June 4, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL SAMPLE WAS NOT RETURNED FOR FURTHER EVALUATION OF THE POTENTIAL DEFECT; HOWEVER, A PHOTOGRAPH OF THE DEVICE WAS PROVIDED AND CONFIRMED THE REPORTED INCIDENT. A ROOT CAUSE WAS NOT IDENTIFIED. ALL INFORMATION REASONABLY KNOWN AS OF 03-JUN-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.

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE WAS NOT RETURNED FOR FURTHER EVALUATION OF THE POTENTIAL DEFECT; HOWEVER, A PHOTOGRAPH OF THE DEVICE WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 16-APR-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

    AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2021-00059 FOR THE SECOND EVENT. IT WAS REPORTED THE PATIENT RETURNED TO INTERVENTIONAL RADIOLOGY (IR) FOR A DISPLACED NASO-JEJUNOSTOMY (NJ) TUBE RECENTLY. THE TUBE WAS ALREADY OUT BY THE TIME THE PATIENT ARRIVED TO IR. THE FAMILY MEMBER BROUGHT IN THE TUBE AND THE CLINICIAN NOTED A SMALL TEAR (APPROXIMATELY 2CM IN LENGTH) LOCATED ABOUT 40CM FROM THE DISTAL TIP. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579143 UNKNOWN (NEOMED AND NEOCONNECT) NASOGASTRIC TUBE DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT) KNT AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1