BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY* LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE, 22 FR, 2.7 CM, 45 CM

    MDR report key: 6946175 · Received October 12, 2017

    Report

    Report Number
    9611594-2017-00138
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Date of Event
    August 2, 2017
    Report Date
    December 16, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    KNT
    UDI-DI
    10680651956740
    PMA / PMN Number
    K926581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, AA6095N26, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF 28-DEC-2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. 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 DEVICE IS REPORTED TO BE AVAILABLE BUT WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. UPON COMPLETION OF THE INVESTIGATION; A FOLLOW-UP REPORT WILL BE FILED. ALL INFORMATION REASONABLY KNOWN AS OF 12-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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDWATCH, FDA REPORT NUMBER FDA 3500 FORM 5071402, WAS RECEIVED STATING, "PATIENT HAD EXISTING J TUBE INSERTED (B)(6) 2016 IN OUR DEPARTMENT. THE PATIENT WAS ON OUR TABLE FOR REPLACEMENT (B)(6) 2017 AND WE DISCOVERED THAT THE TUBE WAS BROKEN, A SCOUT FILM BEFORE WE START AND THE SCOUT APPEARED TO SHOW A DISCONNECT IN THE CATHETER SUGGESTIVE OF A CATHETER FRACTURE. SURE ENOUGH IT WAS FRACTURED AND THE LARGER DISTAL PORTION (ESSENTIALLY THE WHOLE TUBE EXCEPT FOR A SMALL PORTION WHICH GOES INTO THE STOMACH REMAINED) APPEARED TO HAVE MIGRATED INTO THE LARGE BOWEL. THE PROXIMAL END OF THE G-J TUBE WAS REMOVED OVER THE WIRE, BUT THE BROKEN SECTION DISTALLY STAYED IN THE BOWEL GENERAL SURGERY WAS CONSULTED, BUT UNLIKELY TO HAVE SURGICAL REMOVAL BASED ON NO SHARP EDGES THAT COULD CAUSE PERFORATION." ADDITIONAL INFORMATION RECEIVED 11-OCT-2017 STATED THE USER REPORTED THAT THE PIECE THAT BROKE OFF AND MIGRATED WAS DETERMINED TO NOT BE OF ANY HARM TO THE PATIENT AND SURGICAL INTERVENTION WAS NOT PERFORMED. NO FURTHER INFORMATION IS AVAILABLE ON INCIDENT OR PATIENT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724165 MIC-KEY* LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE, 22 FR, 2.7 CM, 45 CM DH EF BALLOON TUBES PRODUCTS KNT HALYARD HEALTH 0270-22-2.7-45 AA6095N26 10680651956740

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR