BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE

    MDR report key: 10424863 · Received August 19, 2020

    Report

    Report Number
    9611594-2020-00157
    Event Type
    Malfunction
    Date Received
    August 19, 2020
    Report Date
    August 19, 2020
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    K993138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 18 AUG 2020 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. 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

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2020-00156 FOR THE FIRST REPORT. IT WAS REPORTED THAT THE "BALLOON WAS INFLATED WITH AIR, NOT USING DISTILLED WATER. AFTER THAT NUTRITION WAS INJECTED WHILE THE DISTAL END OF THE TUBE WAS IN THE ABDOMINAL CAVITY. NUTRITION CAME INTO THE ABDOMINAL CAVITY." THE USER HAS ADMITTED THAT THEIR PROCEDURE WAS INCORRECT. ADDITIONAL INFORMATION RECEIVED 04-AUG-2020 INDICATED THE PATIENT HAD A FEVER AND ABDOMINAL PAIN THE DAY FOLLOWING THE EVENT. THE PATIENT'S CURRENT HEALTH STATUS IS "RECOVERED." ADDITIONAL INFORMATION RECEIVED 05-AUG-2020 INDICATED THE DEVICE IS FROM THE "0620" PRODUCT FAMILY, BUT THE EXACT MODEL NUMBER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891964 UNKNOWN MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR