BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO STANDARD PEG KIT - PULL METHOD

    MDR report key: 9663271 · Received February 4, 2020

    Report

    Report Number
    3006646024-2020-00002
    Event Type
    Malfunction
    Date Received
    February 4, 2020
    Date of Event
    January 13, 2020
    Report Date
    April 14, 2020
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770458854
    PMA / PMN Number
    K882867
    Removal / Correction Number
    TBD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H9: A FIELD ACTION WAS INITIATED ON 16-MAR-2020. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION; HOWEVER, A DEVICE FROM THE SAME LOT WAS RETURNED FROM THE USER. THIS DEVICE WAS EVALUATED AND THE REPORTED INCIDENT WAS CONFIRMED. POTENTIAL ROOT CAUSES WERE IDENTIFIED AND ARE BEING ADDRESSED. ALL INFORMATION REASONABLY KNOWN AS OF 13 APR 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. 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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR LOT 0203214820 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 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

    IT WAS REPORTED THAT "THERE WAS GAS (FROM THE STOMACH) COMING OUT RIGHT AFTER WE PLACED IT [CORFLO MAX PEG (12 FR)] AND OPENED IT BUT WHEN THEY WERE READY TO INFUSE FLUID, THEY WERE UNABLE TO DO SO. IT SO HAPPENS, WE HAD TO CHANGE THAT TUBE ON POD [POST-OPERATIVE DAY] # 2, WHEN IT WAS NOT VERY SAFE TO DO, BUT WE VERY CAREFULLY DID. THE TUBE HAD A 'DIAPHRAGM' CAUSING AN OBSTRUCTION AT THE TIP BEFORE THE DISC WITH THE SPONGE. ADDITIONAL INFORMATION RECEIVED 16-JAN-2020 INDICATED THAT THERE WERE NO ADVERSE EFFECTS FOLLOWING THE REDO PROCEDURE. PRODUCT LOT CODE WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED 17-JAN-2020 INCLUDED LIMITED PATIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131447 CORFLO STANDARD PEG KIT - PULL METHOD DH CPK PEG INITIAL PLACEMENT PRODUCTS KNT AVANOS MEDICAL INC. 30-6012 0203214820 00350770458854

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO