BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 16FR DILATOR

    MDR report key: 10399012 · Received August 12, 2020

    Report

    Report Number
    9611594-2020-00153
    Event Type
    Malfunction
    Date Received
    August 12, 2020
    Date of Event
    June 21, 2020
    Report Date
    October 8, 2020
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KGC
    UDI-DI
    00350770984308
    PMA / PMN Number
    K080253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR LOT 30012239 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, THE DISTRIBUTOR PERFORMED AN EVALUATION WHICH CONFIRMED THE REPORTED INCIDENT. ACCORDING TO THE DISTRIBUTOR'S REPORT, THERE WERE NO OBVIOUS SIGNS OF MOLDING DEFORMITY OR MANUFACTURING MATERIAL WEAKNESS IDENTIFIED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 02 OCT 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 DEVICE HISTORY RECORD FOR LOT 30012239 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 12 AUG 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 THREE GASTROPEXY SUTURES WERE INSERTED AT TIME OF INITIAL INSERTION. ONE SUTURE (3 O'CLOCK POSITION) HAD FALLEN OFF BY DAY 3 POST-INSERTION. ON DAY 13 POST-INSERTION, ONE OF THREE SUTURES REMAINED (9 O'CLOCK POSITION SUTURE WAS NOT PRESENT). ADDITIONAL INFORMATION RECEIVED 03-AUG-2020 INDICATED THERE WAS NO PATIENT INJURY AND NO NEED FOR MEDICAL INTERVENTION; THE PATIENT WAS OBSERVED. THE PATIENT'S CONDITION WAS REPORTED AS "PATIENT WELL WHEN THE REPORTING FORM WAS WRITTEN." ACCORDING TO THE DISTRIBUTOR, NO OBVIOUS SIGNS OF A MANUFACTURING RELATED ISSUE WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863176 INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 16FR DILATOR DH EF PERC PLACEMENT PRODUCTS KGC AVANOS MEDICAL INC. 98430 30012239 00350770984308

    Patients

    Seq Age Sex Outcome Treatment
    1