BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK 2 EAS ELECTROMAGNETIC TRANSMITTING STYLET AND CORFLO FEEDING TUBE

    MDR report key: 6504285 · Received April 19, 2017

    Report

    Report Number
    3009124963-2017-00013
    Event Type
    Injury
    Date Received
    April 19, 2017
    Date of Event
    January 28, 2017
    Report Date
    May 24, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    KNT
    PMA / PMN Number
    K821906
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE ACTUAL DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS NOT KNOWN. AS THE LOT IS UNKNOWN, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS NOT PERFORMED. RESULTS: AS THE DEVICE WAS UNAVAILABLE FOR ANALYSIS, NO METHODS WERE PERFORMED. THEREFORE, RESULTS CANNOT BE OBTAINED. CONCLUSIONS: THE DEVICE WAS NOT RETURNED TO HALYARD FOR EVALUATION THEREFORE, WE ARE UNABLE TO DETERMINE THE CAUSE FOR THE REPORTED EVENT. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 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 YET RETURNED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 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). 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 A HALYARD HEALTH PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA REPORT SOURCE - INADVERTENTLY OMITTED FROM INITIAL REPORT. ALL INFORMATION REASONABLY KNOWN AS OF 16-MAY-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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MDR USER FACILITY REPORT NUMBER (B)(4): "A NASOGASTRIC JEJUNAL TUBE (NGJ) WAS INSERTED IN THE PATIENT IN INTERVENTIONAL RADIOLOGY. THE PATIENT WAS ADMITTED TO THIS FACILITY APPROXIMATELY 10 DAYS AFTER NGJ INSERTION WITH FEEDING INTOLERANCE AND FREE ABDOMINAL AIR NOTED ON THE X-RAY. THE PATIENT SUBSEQUENTLY UNDERWENT ABDOMINAL EXPLORATORY LAPAROTOMY AND PRIMARY REPAIR OF THE JEJUNAL PERFORATION LOCATED AT THE TIP OF THE NASOGASTRIC JEJUNAL TUBE." NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285747 CORTRAK 2 EAS ELECTROMAGNETIC TRANSMITTING STYLET AND CORFLO FEEDING TUBE DH CPK NG TUBE KNT HALYARD HEALTH 20-9368TRAK2 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other| R