BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE

    MDR report key: 17857912 · Received October 2, 2023

    Report

    Report Number
    9611594-2023-00143
    Event Type
    Malfunction
    Date Received
    October 2, 2023
    Report Date
    October 2, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KGC
    UDI-DI
    00350770984322
    PMA / PMN Number
    K080253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. A ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 27 SEP 2023 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 REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED MULTIPLE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING MULTIPLE DIFFERENT PATIENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 9611594-2023-00141 FOR THE FIRST REPORT REFER TO 9611594-2023-00142 FOR THE SECOND REPORT REFER TO 9611594-2023-00144 FOR THE FOURTH REPORT IT WAS REPORTED, "PUBLICATION OF A 10-YEAR STUDY (700 FITTINGS) CARRIED OUT BY OUR TEAM OF PAEDIATRIC GASTROENTEROLOGISTS, HIGHLIGHTING A (B)(4) RATE OF OCCURRENCE OF ADVERSE EVENTS (ALL MINOR) (E.G... MINOR INFECTIONS, STAPLE EXTERIORISATION) ASSOCIATED WITH GASTROSTOMY INTRODUCER KITS." NO MEDICAL INTERVENTIONS WERE REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 9SEP2023, ¿PERIOD OF OCCURRENCE 2010-2020.¿ PERIOD OF OCCURRENCE 2010-2020 PUBLICATION OF A 10-YEAR STUDY (700 POSES) CARRIED OUT BY OUR TEAM OF PEDIATRIC GASTROENTEROLOGISTS AND PUTTING IN EVIDENCE A RATE OF OCCURRENCE OF ADVERSE EFFECTS (ALL MINOR) OF (B)(4) (EG GRANULOMAS, MINIMAL INFECTIONS, EXTERNALIZATION OF STAPLES) RELATED TO GASTROSTOMY INTRODUCTION KITS. JEAN-BART C, C., AUMAR, M., LEY, D. ET AL. COMPLICATIONS OF ONE-STEP BUTTON PERCUTANEOUS ENDOSCOPIC GASTROSTOMY IN CHILDREN."EUR J PEDIATR 182, 1665¿1672 (2023). HTTPS://DOI.ORG/10.1007/S00431-023-04822-7

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1761606 INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE DH EF PERC PLACEMENT PRODUCTS KGC AVANOS MEDICAL INC. 98432 UNKNOWN 00350770984322

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown