BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO PEG KIT WITH ENFIT CONNECTOR

    MDR report key: 12682370 · Received October 22, 2021

    Report

    Report Number
    3006646024-2021-00019
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    October 6, 2021
    Report Date
    December 21, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770462073
    PMA / PMN Number
    K882867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 20 DEC 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 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 SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. THE DEVICE HISTORY RECORD FOR LOT 20020880 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 21 OCT 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. 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 COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A REPORT RECEIVED FROM THE MHRA ON (B)(6) 2021 THAT THE REPORTER "VISITED THIS GENTLEMAN AS ARRANGED TO TRACTION REMOVE HIS 16FR CORFLO PERCUTANEOUS ENDOSCOPIC GASTROSTOMY ( PEG). THE PEG EXTERNAL LENGTH WAS VERY SHORT APPROXIMATELY 5 INCHES. WHEN TRACTION REMOVING THE PEG HE WAS VERY TENSE AND WAS UNABLE TO RELAX HIS STOMACH MUSCLES, THE EXTERNAL TUBE DETACHED FROM THE INTERNAL BUMPER AND I WAS UNABLE TO VISUALIZE THE BUMPER IN THE STOMA TRACT. I INSERTED A MEASURING DEVICE INTO THE STOMA TRACT AND COULD NOT FEEL THE BUMPER INTERNALLY. STOMA TRACT MEASURED FOR BUTTON BALLOON GASTROSTOMY AND BALLOON GASTROSTOMY PLACED AS PER POLICY. ADVICE GIVEN TO CARE HOME STAFF RE THE BUMPER PASSING THROUGH DIGESTIVE TRACT AND SIGNS AND SYMPTOMS TO LOOK OUT FOR THAT MAY SUGGEST AN OBSTRUCTION. ADVISED TO MONITOR BOWEL MOTIONS AND CONTACT GP IF ANY MEDICAL CONCERNS. REASSURANCE GIVEN THAT THE BUMPER IS VERY SMALL AND SOFT AND SHOULD PASS THROUGH SYSTEM. SPOKE WITH GASTROENTEROLOGIST AND DISCUSSED INCIDENT AND CONSULTANT AGREED WITH CARE PLAN."

    Description of Event or Problem · 0

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3006646024-2021-00020 FOR THE SECOND REPORT. IT WAS REPORTED THAT "THE INTERNAL BUMPER SEPARATED FROM THE TUBE WHILST TRACTION REMOVING THE PEG TUBE. THIS LEFT THE INTERNAL BUMPER INSIDE THE PATIENT." THE PEG TUBE HAD BEEN PLACED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1576478 CORFLO PEG KIT WITH ENFIT CONNECTOR DH CPK PEG INITIAL PLACEMENT PRODUCTS KNT AVANOS MEDICAL INC. 50-6016E1 20020880 00350770462073

    Patients

    Seq Age Sex Outcome Treatment
    1 Male