BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO SAFETY PEG KIT - PULL METHOD

    MDR report key: 8922157 · Received August 22, 2019

    Report

    Report Number
    3006646024-2019-00014
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Date of Event
    June 14, 2019
    Report Date
    October 11, 2019
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    20815149021557
    PMA / PMN Number
    K882867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. ONE USED SAMPLE WAS RECEIVED WITHOUT PRODUCT PACKAGING. THE PRODUCT DOES NOT CONTAIN A LOT NUMBER IDENTIFICATION. BRANDING IS VISIBLE AS "CORPAK YELLOW." THE TUBING IS DISCOLORED, BEING DARKER AT THE DISTAL END. THE BUMPER IS NOT ATTACHED AND WAS NOT RETURNED. THE DISTAL END WAS EXAMINED UNDER MAGNIFICATION; THERE ARE JAGGED REMNANTS OF THE BUMPER COVER ON THE OUTER SURFACE OF THE TUBING. TUBING DOES NOT EXHIBIT TEARS OR CUTS. THE ROOT CAUSE IS UNKNOWN. ALL INFORMATION REASONABLY KNOWN AS OF 09 OCT 2019 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 HALYARD HEALTH 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

    IT WAS DISCOVERED ON 30-SEP-2019 THAT 3006646024-2019-00015 IS A DUPLICATE OF THIS REPORTED EVENT. FROM THAT REPORT, "IT WAS REPORTED THAT THERE WAS A DISPLACEMENT OF THE PEG TUBE WITH THE INTERNAL BUMPER MISSING. A NEW BALLOON GASTROSTOMY TUBE WAS INSERTED. PATIENT ADVISED THAT BUMPER SHOULD PASS THROUGH BOWEL MOVEMENTS, BUT TO REPORT TO A&E SHOULD HE EXPERIENCE SYMPTOMS OF OBSTRUCTION."

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2019 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 HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE "DISPLACED WITHOUT INTERNAL BUMPER. INTERNAL BUMPER THEREFORE RETAINED." ADDITIONAL INFORMATION RECEIVED INDICATED NO INJURIES REPORTED, BUT MEDICAL INTERVENTION WAS REQUIRED TO OBTAIN PART OF THE DEVICE. REQUIRED TUBE REPLACEMENT. FURTHER ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713104 CORFLO SAFETY PEG KIT - PULL METHOD DH CPK PEG INITIAL PLACEMENT PRODUCTS KNT AVANOS MEDICAL INC. 50-6016 UNKNOWN 20815149021557

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR