BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR DILATOR

    MDR report key: 14215497 · Received April 26, 2022

    Report

    Report Number
    9611594-2022-00046
    Event Type
    Malfunction
    Date Received
    April 26, 2022
    Date of Event
    February 21, 2022
    Report Date
    April 26, 2022
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KGC
    UDI-DI
    00350770984322
    PMA / PMN Number
    K080253
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30129217,IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF 21-APR-2022 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 · 0

    IT WAS REPORTED " THE PATIENT HAD A GASTROSTOMY TUBE PLACED ON (B)(6) 2021. ON (B)(6) 2022, THE PATIENT HAD AN EMERGENCY CONSULTATION FOR ABDOMINAL PAIN, AN INFLAMMATORY PLACARD WITH PUS DISCHARGE AT THE GASTROSTOMY ORIFICE. DURING THE CARE, REMOVAL OF ONE OF THE ANCHORS THROUGH THE STOMA ORIFICE. AN ABDOMINO-PELVIC SCANNER WAS PERFORMED, BUT NO SUBCUTANEOUS ABSCESS WAS FOUND. THE BIOLOGICAL WORK-UP DID NOT REVEAL ANY INFLAMMATORY SYNDROME. ACCORDING TO THE DOCTOR WHO PLACED THE PROBE, ONE OF THE ANCHORS COULD HAVE BEEN POSITIONED OUTSIDE THE STOMACH DURING THE PLACEMENT. THE ANCHOR WAS VISIBLE IN THE ABDOMINAL WALL DURING A COMPUTED TOMOGRAPHY (CT). MEDICAL TREATMENT IN PLACE: INITIATION OF ANTIBIOTHERAPY (PRISTINAMYCIN) FOR 8-DAYS TO MANAGE THE INFECTION. THE GASTROSTOMY REMAINED FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968802 INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR DILATOR DH EF PERC PLACEMENT PRODUCTS KGC AVANOS MEDICAL INC. 98432 30129217 00350770984322

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Other