BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH ENFIT CONNECTOR

    MDR report key: 11960004 · Received June 8, 2021

    Report

    Report Number
    9611594-2021-00078
    Event Type
    Injury
    Date Received
    June 8, 2021
    Date of Event
    March 31, 2021
    Report Date
    June 8, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770459974
    PMA / PMN Number
    K821906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD FOR LOT 30107617 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 08 JUN 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 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 PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2021-00077 FOR THE FIRST REPORT. IT WAS REPORTED THAT A NASOGASTRIC (NG) TUBE WAS PLACED POST-THROMBECTOMY AND WAS REPLACED UPON ARRIVAL TO NEURO CRITICAL CARE DUE TO NON-PATENCY. A KIDNEY, URETER, AND BLADDER X-RAY (KUB) WAS DONE TO CONFIRM PLACEMENT OF THE NEW NG TUBE, WHICH INDICATED LEFT LUNG PLACEMENT WITH POSSIBLE SMALL PNEUMOTHORAX. AN X-RAY PERFORMED LATER INDICATED THAT THE PNEUMOTHORAX HAD WORSENED AND THE LEFT LUNG WAS COLLAPSED. DUE TO WORSENING CO-MORBIDITIES (CEREBRAL EDEMA), THE PATIENT WAS PLACED IN COMFORT CARE AND NO FURTHER INTERVENTION WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857150 CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH ENFIT CONNECTOR DH CPK NG TUBES KNT AVANOS MEDICAL INC. 40-1362 30107617 00350770459974

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR