BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO PEG KIT WITH ENFIT CONNECTOR

    MDR report key: 12682346 · Received October 22, 2021

    Report

    Report Number
    3006646024-2021-00020
    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.

    Description of Event or Problem · 0

    PER ADDITIONAL INFORMATION PROVIDED BY THE REPORTER ON 20 DEC 2021, "I VISITED THE PATIENT TO TRACTION REMOVE HIS PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) AND REPLACE WITH A BALLOON GASTROSTOMY. ON TRACTION REMOVAL OF THE PEG THE INTERNAL BUMPER OF THE PEG DETACHED FROM THE EXTERNAL TUBING. I WAS UNABLE TO SEE THE RETAINED BUMPER IN THE TRACT. I INSERTED THE REPLACEMENT BALLOON GASTROSTOMY AND COULD NOT FEEL THE BUMPER IN THE TRACT. I INSERTED A BALLOON GASTROSTOMY AS PER POLICY. I ADVISED THE PATIENT AND HIS WIFE OF THE INCIDENT AND ADVISED RE THE BUMPER PASSING THROUGH THE DIGESTIVE TRACT AND TO OBSERVE FOR ANY SIGNS OR SYMPTOMS OF AN OBSTRUCTION BUT GAVE REASSURANCE THAT THE INTERNAL BUMPER WAS VERY SMALL AND SOFT AND SHOULD PASS THROUGH. I ADVISED I WOULD DISCUSS THE INCIDENT WITH THE CONSULTANT WHICH I DID AND THEY AGREED WITH THE CARE PLAN."

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. 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. 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).

    Description of Event or Problem · 1

    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 SECOND OF TWO REPORTS. REFER TO 3006646024-2021-00019 FOR THE FIRST 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) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583630 CORFLO PEG KIT WITH ENFIT CONNECTOR DH CPK PEG INITIAL PLACEMENT PRODUCTS KNT AVANOS MEDICAL INC. 50-6016E1 UNKNOWN 00350770462073

    Patients

    Seq Age Sex Outcome Treatment
    1 Male