BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR DILATOR

    MDR report key: 12137602 · Received July 8, 2021

    Report

    Report Number
    9611594-2021-00095
    Event Type
    Injury
    Date Received
    July 8, 2021
    Report Date
    September 7, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KGC
    UDI-DI
    00350770984322
    PMA / PMN Number
    K080253
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D4. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. DURING REVIEW OF THE COMPLAINT IT WAS DETERMINED THAT THE LOT NUMBER PROVIDED IS NOT FOR THE INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE. THE CUSTOMER INDICATED THE LOT NUMBER FOR THE INTRODUCER KIT IS NOT AVAILABLE. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A PHOTO WAS PROVIDED BY THE CUSTOMER AND THE REPORTED INCIDENT WAS CONFIRMED. HOWEVER, A ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 03 SEP 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 · 0

    THE INVESTIGATION REMAINS IN PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 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 21 CFR 803, 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 08-JUL-2021 CLARIFIED THAT "THE GUIDEWIRE WASN'T MISSED. DURING THE PUSHING THE GUIDEWIRE WAS VERY SHARP KINKED."

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A PHOTO WAS PROVIDED BY THE CUSTOMER. ALL INFORMATION REASONABLY KNOWN AS OF 08 JUL 2021 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). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "WHEN THE DILATION SYSTEM WAS INSERTED OVER THE GUIDE WIRE, IT KINKED SHARPLY AND PERFORATED THE POSTERIOR WALL OF THE STOMACH WITH THE KINKED WIRE TIP AND THE DILATOR." ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2021 INDICATED MEDICAL TREATMENT CONSISTED OF "PRIMARY ENDOSCOPIC CLIPPING OF THE LEAKAGE, RELIEF OF THE PNEUMOPERITONEUM BY MEANS OF PUNCTURE AND MED[ICATION]. ANTIBIOTICS AND PAINKILLERS WERE NECESSARY FOR SEVERAL DAYS." PATIENT EXPERIENCED "LOCAL PERITONITIS" WHICH WAS TREATED WITH "CONSERVATIVE THERAPY." PATIENT'S CURRENT CONDITION IS "NO OP, GOOD AZ AND HEALING OF THE PEG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035413 INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR DILATOR DH EF PERC PLACEMENT PRODUCTS KGC AVANOS MEDICAL INC. 98432 UNKNOWN 00350770984322

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other| R