BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE

    MDR report key: 20294797 · Received September 24, 2024

    Report

    Report Number
    9611594-2024-00202
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    August 15, 2024
    Report Date
    September 24, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KGC
    UDI-DI
    00350770984315
    PMA / PMN Number
    K080253
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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; THEREFORE, THE UDI-PI IS UNAVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 24 SEP 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

    IT WAS REPORTED, ¿PATIENT HAD PUSH PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PROCEDURE ON (B)(6) 2024. THE PROCEDURE WAS INITIALLY UNCOMPLICATED. THAT EVENING, PATIENT HAD INCREASE IN ABDOMINAL PAIN AND BULGING ABDOMEN. ON (B)(6) 2024, LAPAROTOMY PERFORMED SHOWING TUBE FEEDING IN THE FREE ABDOMINAL CAVITY AND PNEUMOPERITONEUM. IT WAS VISIBLE THAT THE BALLOON WAS WELL AGAINST THE ABDOMINAL WALL, AND TWO ANCHORS ALSO AGAINST THE ABDOMINAL WALL, BUT THE THIRD SAGGED 1CM. NEXT TO THE INSERTION OF THE STOMACH, THE STOMACH HAD SAGGED AND BECAUSE OF THAT, THE FOOD RAN INTO THE ABDOMINAL CAVITY.¿ THE PATIENT IS NOW ON TOTAL PARENTERAL NUTRITION (TPN) AND SINCE YESTERDAY, IS TUBE FEEDING VIA PEG. PATIENT WAS REPORTED TO BE CLINICALLY BETTER. PER ADDITIONAL INFORMATION RECEIVED ON 05SEP2024, PATIENT RECEIVED ANTIBIOTICS AFTER LAPAROTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138304 INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE DH EF PERC PLACEMENT PRODUCTS KGC AVANOS MEDICAL INC. 98431 UNKNOWN 00350770984315

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Female Other| R 8110-14LV AVANOS GASTROSTOMY TUBE.