BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT WITH ENFIT CONNECTORS - 24 FR

    MDR report key: 14243895 · Received April 28, 2022

    Report

    Report Number
    3006646024-2022-00012
    Event Type
    Injury
    Date Received
    April 28, 2022
    Date of Event
    March 29, 2022
    Report Date
    April 28, 2022
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770446295
    PMA / PMN Number
    K924065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD FOR LOT 30117334 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 28 APR 2022 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 COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NURSE HAD DIFFICULTY REMOVING THE PLASTIC SHEATH FROM THE SCALPEL PROVIDED IN THE KIT. THE NURSE ATTEMPTED TO USE SCISSORS TO TRY TO PUSH OFF THE PLASTIC SHEATH, BEFORE GRABBING THE COVER WITH GLOVED HANDS AND PULLING WITH "FULL FORCE," RESULTING IN THE COVER COMING LOOSE AND THE SHARP EDGE OF THE SCALPEL CUTTING THE INSIDE OF HER RIGHT THUMB, GIVING A "1CM WIDE AND HALF DEEP CUT", WHICH BLED PROFUSELY. THE NURSE WAS WEARING STERILE GLOVES THAT HAD NOT BEEN CONTAMINATED WITH PATIENT FLUIDS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142190 MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT WITH ENFIT CONNECTORS - 24 FR DH EF PEG INITIAL PLACEMENT PRODUCTS KNT AVANOS MEDICAL INC. 9640-24 30117334 00350770446295

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other