BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR

    MDR report key: 11345934 · Received February 18, 2021

    Report

    Report Number
    9611594-2021-00024
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    August 9, 2020
    Report Date
    April 9, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    FPD
    UDI-DI
    00350770460314
    PMA / PMN Number
    K083210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS AN EXACT LOT NUMBER WAS PROVIDED. INSPECTION ACTIVITIES TO IDENTIFY ABNORMALITIES ON THE DEVICE COMPONENTS ARE ALREADY IN PLACE AT THE MANUFACTURING SITE AND THERE WERE NO IDENTIFIED FAILURES IN PROCESS FOR REPORTED FAILURE MODE. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 07 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.

    Additional Manufacturer Narrative · 1

    PATIENT CODE 4581 - APPROPRIATE CLINICAL SIGNS, SYMPTOMS, CONDITIONS TERM / CODE NOT AVAILABLE: PATIENT RE-INTUBATED. THE EXACT LOT NUMBER IS UNKNOWN; HOWEVER, TWO POTENTIAL LOTS WERE PROVIDED AND A REVIEW OF THE DEVICE HISTORY RECORDS IS IN-PROGRESS. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 18 FEB 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 COMP (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NGT [NASOGASTRIC TUBE] WAS INSERTED ON (B)(6) 2020. IT WAS FOUND TO HAVE A LEAK/SPLIT AT THE 52CM MARK WHEN IT WAS REMOVED, AND THE PATIENT WAS FOUND TO HAVE "MILKY" COLORED SPUTUM. THE PATIENT REQUIRED REINTUBATION RELATED TO RESPIRATORY FAILURE. ADDITIONAL INFORMATION RECEIVED 08-FEB-2021 INDICATED THE PATIENT WAS "DISCHARGED SATISFACTORILY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240133 CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR DH CPK NG TUBES FPD AVANOS MEDICAL INC. 40-7368 UNKNOWN 00350770460314

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other