BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTO

    MDR report key: 12356569 · Received August 23, 2021

    Report

    Report Number
    9611594-2021-00110
    Event Type
    Malfunction
    Date Received
    August 23, 2021
    Date of Event
    July 23, 2021
    Report Date
    August 23, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    FPD
    UDI-DI
    00350770460420
    PMA / PMN Number
    K083210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 23-AUG-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).

    Description of Event or Problem · 1

    IT WAS REPORTED THE NASOGASTRIC TUBE WAS "OVER PRESSURIZED AND BLEW OUT THE NG TUBE; PIECES WERE LEFT INSIDE PATIENT. NO INJURY." THE PATIENT HAD TO BE TAKEN INTO OPERATING ROOM PIECES. ADDITIONAL INFORMATION WAS RECEIVED ON 18-AUG-2021 FROM MEDWATCH/ FDA USER FACILITY REPORT # MW 5102839 STATING: ENTERAL FEEDING TUBE WAS IDENTIFIED TO BE NON-INTACT AFTER REMOVAL. UPON FURTHER INVESTIGATION IT IS BELIEVED THAT A PARTIAL OBSTRUCTION IN THE TUBE MAY HAVE RESULTED INCREASED PRESSURE DURING MEDICATION ADMINISTRATION, CAUSING THE TUBE TO RUPTURE. THIS SCENARIO WAS RECREATED BY CREATING AN OBSTRUCTION IN A NEW TUBE THAT HAD NOT BEEN PLACED IN A PATIENT. THIS TEST REVEALED THE TUBE EXPANDING BALLOON LIKE FASHION WHEN MINIMAL PRESSURE WAS APPLIED. THE SIDE PORT OF THE TUBE IS ENFIT CONNECTION WHICH HAS A SECURE CAP THAT DOES NOT "POP-OFF" (LIKE A SLIP TIP CONNECTION), THUS ANY EXCESS PRESSURE IS NOT AUTOMATICALLY RELIEVED FROM THE TOP WHICH CAN CAUSE THE TUBE TO RUPTURE. UNFORTUNATELY IT IS NOT OBVIOUS THAT AN EXCESS AMOUNT OF FORCE US BEING EXERTED, AS THE TUBE EXPANDS EASILY AND VERY LITTLE RESISTANCE IS APPRECIATED. WE DO NOT BELIEVE THIS ISSUE TO BE ISOLATED TO A SPECIFIC LOT NUMBER OR TUBE SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253064 CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTO DH CPK NG TUBES FPD AVANOS MEDICAL INC. 40-9366 UNKNOWN 00350770460420

    Patients

    Seq Age Sex Outcome Treatment
    1