BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC GASTRIC-JEJUNAL FEEDING TUBE KIT - ENDOSCOPIC/RADIOLOGIC PLACEMENT - 18 FR

    MDR report key: 11282717 · Received February 4, 2021

    Report

    Report Number
    9611594-2021-00010
    Event Type
    Injury
    Date Received
    February 4, 2021
    Date of Event
    December 5, 2020
    Report Date
    March 26, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770954844
    PMA / PMN Number
    K921370
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30059056, 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 26-MAR-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.

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 03-FEB-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).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S FAMILY MEMBER DESCRIBED THE TUBING AS HAVING A CLEAR, ROUND, PLASTIC PLATE THAT WAS HELD IN PLACE WITH A BALLOON. THE FAMILY MEMBER STATED THE PATIENT BEGAN TO EXPERIENCE INCREASED DRAINAGE AND PAIN AROUND (B)(6) 2020. THE PATIENT WAS RECEIVING LEVODOPA/CARBIDOPA. ON (B)(6) 2020 THE PATIENT WENT TO THE EMERGENCY DEPARTMENT FOR THE EVENTS AND WAS DIAGNOSED WITH A STOMA SITE INFECTION. THE PATIENT WAS TREATED WITH ORAL BACTRIM. THE EVENT OF STOMA INFECTION HAS RESOLVED. THE PEG TUBE WAS LAST REPLACED ON (B)(6) 2020. THE FAMILY REPORTED THE PATIENT TOOK HIS LAST DOSE OF ANTIBIOTICS AND HE WOULD UNDERGO TUBING REPLACEMENT VIA INTERVENTIONAL RADIOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178026 MIC GASTRIC-JEJUNAL FEEDING TUBE KIT - ENDOSCOPIC/RADIOLOGIC PLACEMENT - 18 FR DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. 0250-18 30059056 00350770954844

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ORAL BACTRIM