BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORFLO PEG KIT WITH ENFIT CONNECTOR

    MDR report key: 11961650 · Received June 8, 2021

    Report

    Report Number
    3006646024-2021-00007
    Event Type
    Death
    Date Received
    June 8, 2021
    Report Date
    June 30, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770462073
    PMA / PMN Number
    K882867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 30 JUN 2021 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

    ADDITIONAL INFORMATION RECEIVED 10-JUN-2021 INDICATED THE PATIENT DEVELOPED PERITONITIS WITHIN ONE WEEK OF THE PEG PLACEMENT. THE PATIENT DIED AS A RESULT OF THE PERITONITIS AND FOUR LITERS OF FEED IN THE PERITONEUM. THE DEVICE WAS PLACED BY AN EXPERIENCED USER. ADDITIONAL INFORMATION RECEIVED 18-JUN-2021 INDICATED THE DEVICE WAS PLACED ON (B)(6) 2021. THE EXACT DATE OF DEATH IS UNKNOWN, BUT IT WAS WITHIN 10 DAYS OF PLACEMENT.

    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 08 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

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3006646024-2021-00008 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE DEVICE DISPLACED SOON AFTER PLACEMENT, RESULTING IN PERITONITIS. ACCORDING TO THE CUSTOMER, THE DEVICE WAS NOT PULLED AND WAS IDENTIFIED IN THE STOMACH AT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854490 CORFLO PEG KIT WITH ENFIT CONNECTOR DH CPK PEG INITIAL PLACEMENT PRODUCTS KNT AVANOS MEDICAL INC. 50-6016E1 UNKNOWN 00350770462073

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death| O