BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALYARD CORFLO PEG REPLACEMENT FEEDING ADAPTER WITH ENFIT CONNECTOR

    MDR report key: 6811513 · Received August 22, 2017

    Report

    Report Number
    3009124963-2017-00044
    Event Type
    Injury
    Date Received
    August 22, 2017
    Date of Event
    July 16, 2017
    Report Date
    September 22, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    KNT
    UDI-DI
    20815149021588
    PMA / PMN Number
    K882867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER WAS REVIEWED AND DOCUMENTED THAT THE LOT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. ALL INFORMATION REASONABLY KNOWN AS OF 10-OCT-2017 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 HALYARD HEALTH 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 HALYARD HEALTH. HALYARD HEALTH 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).

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 22-AUG-2017 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 HALYARD HEALTH 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 HALYARD HEALTH. HALYARD HEALTH 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 RECEIVED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE PATIENT'S FATHER THAT A PEG ADAPTER SNAPPED INTO TWO PIECES. IT WAS NOTED, THAT AS A RESULT, THE TUBE STAYS OPEN AND EXPOSED FOR CONTAMINATION TO ENTER IN, OR THE STOMACH CAN EMPTY ITSELF UNTIL THE ISSUE IS DISCOVERED. IT WAS NOTED THAT REPORTER BELIEVES THAT BACTERIA WENT IN AND HIS SON BECAME ILL. EXTRA CAUTION WAS NOTED TO BE TAKEN TO PREVENT ADDITIONAL BREAKS. ADDITIONAL INFORMATION RECEIVED ON 25-JUL-2017 FROM THE PATIENT'S FATHER STATED THAT HIS SON BECAME SICK 24 HOURS AFTER A PEG ADAPTER BREAK, WHICH HE BELIEVES CAUSED HIS SON'S CHEST INFECTION. A VISIT TO THE HOSPITAL WAS REQUIRED IN ORDER TO OBTAIN AND ADMINISTER ANTIBIOTICS. THE FATHER NOW USES SELLOTAPE AS A PREVENTATIVE. NO FURTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591944 HALYARD CORFLO PEG REPLACEMENT FEEDING ADAPTER WITH ENFIT CONNECTOR DH CPK PEG INITIAL PLACEMENT PRODUCTS KNT HALYARD HEALTH 50-6112 77611 20815149021588

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R