BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT WITH ENFIT CONNECTORS-14 FR PULL

    MDR report key: 12019115 · Received June 17, 2021

    Report

    Report Number
    3006646024-2021-00011
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Report Date
    June 17, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770446035
    PMA / PMN Number
    K924065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30062781, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF 17-JUN-2021 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. 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 VIA FDA MEDWATCH REPORT 5100693 THE TUBE WAS PLACED ON (B)(6) 2020. THE PATIENT DEVELOPED PAIN WITH FLUSHING AND THE TUBE CRACKED ON (B)(6) 2020. THE PEG BUMPER WAS FOUND TO BE DISPLACED IN THE ANTERIOR ABDOMINAL WALL ON (B)(6) 2020. THE BROKEN DEVICE REQUIRED PEG REMOVAL VIA LAPAROSCOPIC GT ON (B)(6) 2020. THERE WERE NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913839 MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT WITH ENFIT CONNECTORS-14 FR PULL DH EF PEG INITIAL PLACEMENT PRODUCTS KNT AVANOS MEDICAL INC. 8160-14 30062781 00350770446035

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR