BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR

    MDR report key: 12544642 · Received September 28, 2021

    Report

    Report Number
    9611594-2021-00132
    Event Type
    Injury
    Date Received
    September 28, 2021
    Report Date
    September 28, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    FPD
    UDI-DI
    00350770460420
    PMA / PMN Number
    K083210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE WAS NOT RETURNED FOR FURTHER EVALUATION OF THE POTENTIAL DEFECT; HOWEVER, A PHOTOGRAPH OF AN UNUSED 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 27-SEP-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). DEVICE NOT RETURNED, PHOTO PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT # MW5103286 AND THE FOLLOWING INFORMATION WAS PROVIDED: PATIENT FOUND TO HAVE A SMALL BOWEL PERFORATION AFTER USE OF CORPAK. ADDITIONAL INFORMATION RECEIVED 14-SEP-2021 STATED THE PATIENT IS DECEASED DUE TO CO-MORBIDITIES (NOT RELATED TO FEEDING TUBE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442542 CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR DH CPK NG TUBES FPD AVANOS MEDICAL INC. 40-9366 UNKNOWN 00350770460420

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Death| L| O