BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NEO MED NASOGASTRIC TUBE

    MDR report key: 18937297 · Received March 19, 2024

    Report

    Report Number
    3011270181-2024-00034
    Event Type
    Malfunction
    Date Received
    March 19, 2024
    Date of Event
    February 17, 2024
    Report Date
    July 1, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    FPD
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF 16-MAY-2024 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 · 0

    THE ACTUAL DEVICE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 19-MAR-2024 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 COMP (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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. THE SAMPLE DEVICE WAS EXAMINED SHOWING THAT THE TUBING HAD SIGNS OF DAMAGE AND DISCOLORATION. THE BLACK DISCOLORATION STARTED AT 14CM MARKING UNTIL 6CM MARKING BEFORE BOLUS DISTAL END OF THE TUBE. AT 14CM MARKED LOCATION, THE TUBING APPEARED TO HAVE EXPANDED TO FORM A BALLOON SHAPE WHICH BURST OPEN CAUSING THE TUBE TO BREAK INTO 2 PIECES AND BECAME THIN IN THE SURFACE. THE OTHER PIECE (PROXIMAL END) WAS NOT RECEIVED IN THE LAB. AFTER EXAMINING THE BURST PORTION OF TUBE, CLOGGING IN THE TUBING WAS IDENTIFIED BY RUNNING GLOVED FINGERS FROM 14CM MARK OF THE TUBING TOWARDS DISTAL END. A HARDENED FEELING WAS FELT. POWDERY DRIED SUBSTANCE WAS FOUND WHEN EXAMINED UNDER MAGNIFICATION (20X). A ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 01 JUL 2024 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 REPORTED EVENT BUT IS RELAYING THE INFORMATION 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). 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.

    Description of Event or Problem · 0

    AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3011270181-2024-00035 FOR THE SECOND EVENT. REFER TO 3011270181-2024-00036 FOR THE THIRD EVENT. IT WAS REPORTED THERE WAS AN INCIDENT OF THE NASOGASTRIC TUBE FRACTURING DURING USE WHILE INSIDE OF THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024 STATING THE POST PYLORIC TUBE (INDWELLING 12-DAYS) BECAME CLOGGED OVERNIGHT, NURSE ATTEMPTED TO UNCLOG WITH WATER USING PULSING TECHNIQUE. AN X-RAY OBTAINED ON (B)(6) 2024 AM. PER OUR NEW PROTOCOL WHICH SHOWED FRACTURE OF TUBE INSIDE PATIENT WITH LARGE FRAGMENT STILL IN POST PYLORIC POSITION. THE PATIENT REQUIRED EMERGENT ESOPHAGOGASTRODUODENOSCOPY (EGD) FOR REMOVAL UNDER GENERAL ANESTHESIA REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485922 UNKNOWN NEO MED NASOGASTRIC TUBE DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT) FPD AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Female