BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC SAFETY PEG KIT WITH ENFIT® CONNECTORS-20 FR-PULL

    MDR report key: 24845006 · Received April 10, 2026

    Report

    Report Number
    2026095-2026-00024
    Event Type
    Malfunction
    Date Received
    April 10, 2026
    Date of Event
    February 1, 2026
    Report Date
    April 10, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770007854
    PMA / PMN Number
    K924065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD AND UDI NUMBER ARE IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 09-APR-2026 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 VIA FDA MEDWATCH / FDA USER FACILITY REPORTS MW REPORT MW5183903 THE FOLLOWING INFORMATION: TROCAR OF PEG TUBE KIT WAS UNABLE TO BE RETRIEVED FROM PATIENT. APPEARED TO BE LODGED, DID NOT RELEASE APPROPRIATELY. PATIENT HAD TO HAVE SECOND SURGERY TO REMOVE RETAINED TROCAR." NO SAMPLE IS AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED 24-MAR-2026 STATES "THE PATIENT HAD TO UNDERGO ANESTHESIA FOR GENERAL SURGERY TO HAVE FOREIGN BODY (TROCAR) REMOVED FROM ABDOMINAL WALL. THE TROCAR BECAME LODGED WHEN THE GI [GASTROINTESTINAL] PROVIDER WAS PLACING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY [PEG] TUBE. THE TROCAR BECAME LODGED WITHIN THE ABDOMINAL WALL AND WAS UNABLE TO BE REMOVED DURING INITIAL PEG TUBE PLACEMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904904 MIC SAFETY PEG KIT WITH ENFIT® CONNECTORS-20 FR-PULL DH EF PEG INITIAL PLACEMENT PRODUCTS KNT AVANOS MEDICAL INC. 8180-20 3038749 00350770007854

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention