BEUDAMED
    FDA Adverse Event Death Summary report: N

    MIC* TJ FEEDING TUBE KIT 16 FR, 45CM (ENDO/RADIOL)

    MDR report key: 6788102 · Received August 11, 2017

    Report

    Report Number
    9611594-2017-00114
    Event Type
    Death
    Date Received
    August 11, 2017
    Date of Event
    May 24, 2017
    Report Date
    November 29, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    KNT
    UDI-DI
    10680651954807
    PMA / PMN Number
    K921370
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 (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. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION REASONABLY KNOWN AS OF 21AUG2017 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 DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER, AA6193N10, INVOLVED IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. AT THE TIME OF THE DHR REVIEW, THERE WERE NO CHANGES TO THE PROCESS AND/OR EQUIPMENT THAT WOULD HAVE AFFECTED THE MANUFACTURING OF THE DEVICE. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED BY WIFE OF THE PATIENT TO THE DISTRIBUTOR THAT THE PATIENT¿S FEEDING TUBE HAD COME OUT AND HAD COILED INSIDE THE PATIENT. PER THE WIFE, THE RADIOLOGIST HAD TOLD HER THAT PER FLUOROSCOPY TESTING, THE DYE INSERTED INTO THE GASTRIC PORT WAS GOING INTO THE DUODENUM, AND THE DYE INSERTED IN THE JEJUNAL PORT WAS GOING INTO THE GASTRIC LUMEN. THE PATIENT PASSED AWAY ON (B)(6) 2017, AND THE WIFE ALLEGES THAT THE PATIENT WAS NOT GETTING THE PROPER FEEDING. THE WIFE ALSO REPORTS THAT THE PATIENT FELL TWICE AND HAD BLEEDING IN THE BRAIN, AND SLEPT MORE THAN USUAL. PER ADDITIONAL INFORMATION RECEIVED (B)(6) 2017 FROM DR (B)(6), FROM INTERVENTIONAL RADIOLOGY, THERE WAS NO MALFUNCTION OF THE TUBE THAT WAS REMOVED FROM THE PATIENT. THE MISFEEDING OF THE DYE WAS DUE TO THE INCORRECT POSITION OF THE TUBE INSIDE THE PATIENT, AS IT HAD COILED INSIDE THE PATIENT¿S STOMACH, RATHER THAN IN THE JEJUNUM. THE MEDICATION (UNKNOWN) THAT WAS BEING GIVEN TO THE PATIENT WAS SUPPOSED TO BE DELIVERED TO THE JEJUNUM FOR APPROPRIATE ABSORPTION, BUT WAS NOT GIVEN PROPERLY DUE TO THE INCORRECT POSITIONING OF THE FEEDING TUBE. PER ADDITIONAL INFORMATION RECEIVED (B)(6) 2017, A NURSE INVOLVED IN THE REPLACEMENT OF THE DEVICE ON (B)(6) 2017 REPORTED THAT THE DEVICE WAS EXAMINED CAREFULLY, AS THEY WERE AWARE OF THE ALLEGEMENT THAT THE PORTS WERE MISLABELED. THE TEAM DETERMINED THAT THERE WAS NO MISLABELING AND THAT THE PROBLEMS WERE CAUSED BY THE TUBE GETTING PULLED OUT AN ¿FLIPPED¿ ON ITSELF AND COILED, SO THAT WHEN ONE PORT WAS FLUSHED WITH CONTRAST, IT APPEARED TO BE THE OPPOSITE PORT. THE TUBE WAS ORIGINALLY PLACED ON (B)(6) 2017. ON (B)(6) 2017 THE TUBE WAS FOUND OUT OF POSITION, REMOVED, TESTED, FOUND BY STAFF TO BE WITHOUT DEFECTS, AND REPLACED WITH A NEW ONE, WHICH WORKED FINE. NO ADDITIONAL INFORMATION WAS RECEIVED AT THE TIME THIS COMPLAINT WAS FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 02-AUG-2017 THAT STATES THE REPORT REGARDING THE FLUOROSCOPY FINDINGS ON THE PATIENT. FLUOROSCOPIC TUBE INJECTION FINDINGS: THE FINDINGS DEMONSTRATE THE GASTRIC TUBE PORT INJECTION TO FILL THE DUODENUM. NO EXTRAVASATION OF CONTRAST OUTSIDE THE ENTERIC LUMEN IS NOTED. INJECTION OF THE JEJUNAL PORT DEMONSTRATED CONTRAST COLLECTION IN THE GASTRIC LUMEN. NO EXTRAVASATION OF CONTRAST OUTSIDE THE ENTERIC SYSTEM IS NOTED. IMPRESSION: INJECTION OF THE GASTRIC TUBE PORT FILLS THE DUODENUM AND INJECTION OF THE JEJUNAL PORT FILLS THE GASTRIC LUMEN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568346 MIC* TJ FEEDING TUBE KIT 16 FR, 45CM (ENDO/RADIOL) DIGEST HEALTH ENTERAL FEED TUBE KITS KNT HALYARD HEALTH 0250-16 AA6193N10 10680651954807

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| O