BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC GASTRIC-JEJUNAL FEED TUBE, ENFIT, 18 FR

    MDR report key: 19461892 · Received June 4, 2024

    Report

    Report Number
    9611594-2024-00099
    Event Type
    Injury
    Date Received
    June 4, 2024
    Report Date
    November 5, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770445458
    PMA / PMN Number
    K921370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND THE INVESTIGATION REMAINS IN PROGRESS AT THIS TIME. ALL INFORMATION REASONABLY KNOWN AS OF 14-JUN-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 SAMPLE FROM THE REPORTED EVENT WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD AND UDI NUMBER ARE IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 04-JUN-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.

    Description of Event or Problem · 0

    IT WAS REPORTED AND INCIDENT OCCURRED IN "PEJ (PERCUTANEOUS ENDOSCOPIC JEJUNAL) TUBE (DUAL) THAT IS INSERTED IN IR (INTERVENTIONAL RADIOLOGY) BURSTS INSIDE THE PATIENT, PEJ BLOCKED (NO MEDICATION WAS ADMINISTERED) AND UPON TRYING TO UNBLOCK, IT BURST INSIDE THE PATIENT'S BODY, CAUSING HIM TO HAVE A HEMATOMA." THE PATIENT EXPERIENCED PHYSICAL PAIN AND STOMACH CONTENT IN ABDOMINAL CAVITY WAS REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 14-MAY-2024, "INTERVENTIONAL RADIOLOGY FOR TUBES CHANGES (PERCUTANEOUS GASTROTOMY, TUBE VERIFICATIONS IN ANGIO)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659957 MIC GASTRIC-JEJUNAL FEED TUBE, ENFIT, 18 FR DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. 8250-18 30277497 00350770445458

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male