BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMT G-JET

    MDR report key: 6681075 · Received June 30, 2017

    Report

    Report Number
    1526012-2017-00007
    Event Type
    Malfunction
    Date Received
    June 30, 2017
    Date of Event
    May 31, 2017
    Report Date
    June 28, 2017
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    PMA / PMN Number
    K123716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER NARRATIVE: THIS REPORT IS LINKED WITH REPORT # MW5070606. BASED ON THE REPORTED INFORMATION, THERE WAS NO DEATH NOR DID THIS RESULT IN A SERIOUS INJURY, AS DEFINED BY THE FDA. THIS WAS NOT LIFE-THREATENING, NOR DID THIS RESULT IN PERMANENT IMPAIRMENT OR NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT. HOWEVER, THE MALFUNCTION OF THE DEVICE COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE MALFUNCTION WERE TO RECUR. THE LASER LOT NUMBER ON THE DEVICE ASSEMBLY WAS 160413-096. ANALYSIS OF THE RETURNED DEVICE CONSISTED OF A VISUAL AND FUNCTIONAL EVALUATION, AS WELL AS A DEVICE HISTORY REVIEW. OVERALL VISUAL AND FUNCTIONAL TESTING OF THE DEVICE DETERMINED THAT ALL DEVICE COMPONENTS WERE FOUND WITHIN SPECIFICATION AND THE DHR REVIEW INDICATES THAT THE DEVICE WAS PROPERLY ASSEMBLED TO DESIGN AND MANUFACTURING SPECIFICATIONS. THE VISUAL EXAMINATION FOUND THAT THE DEVICE WAS WELL-WORN AND DISCOLORED WITH WHAT APPEARS TO BE A THICK, MILKY SUBSTANCE THROUGHOUT THE LENGTH OF THE TUBING. MULTIPLE AREAS OF RECESSED DIMPLES WERE FOUND ALONG THE LENGTH OF THE TUBING, A PINHOLE TEAR HAD OCCURRED THROUGH THE FILL-LUMEN ALLOWING FOR RESIDUE TO BUILD THROUGHOUT THE LUMEN, AND AREAS OF BULGING WERE NOTICED THROUGHOUT SEVERAL SECTIONS OF THE TUBING. THE CAUSE FOR THE SEPARATING TUBING SUPPORT IS BELIEVED TO BE RELATED TO THE COMBINATION OF EXCESSIVE CLOGGING AND DE-CLOGGING EPISODES, FUNGAL GROWTH, AND POSSIBLY DUE TO EXCESSIVE PRESSURE EXERTED THROUGH THE TUBING TO REMOVE THE CLOGS. THE EXAMINATION DETERMINED THAT THE REPORTED INCIDENT IS AN ISOLATED EVENT AND IS NOT BELIEVED TO HAVE RESULTED FROM A MANUFACTURING DEFECT. WE HAVE ASSIGNED COMPLAINT NUMBER (B)(4) TO THIS REPORT. CORRECTED DATA: THE MANUFACTURER NARRATIVE WAS UPDATED TO LINK THIS REPORT TO VOLUNTARY EVENT REPORT MW5070606 SUBMITTED BY (B)(6) REGARDING THE SAME EVENT. THE VOLUNTARY EVENT REPORT WAS RECEIVED AFTER THE ORIGINAL REPORT WAS SUBMITTED, BUT DOES NOT CHANGE THE EVALUATION OR CONCLUSIONS FROM OUR INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORTED INFORMATION, THERE WAS NO DEATH NOR DID THIS RESULT IN A SERIOUS INJURY, AS DEFINED BY THE FDA. THIS WAS NOT LIFE-THREATENING, NOR DID THIS RESULT IN PERMANENT IMPAIRMENT OR NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT. HOWEVER, THE MALFUNCTION OF THE DEVICE COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE MALFUNCTION WERE TO RECUR. THE LASER LOT NUMBER ON THE DEVICE ASSEMBLY WAS 160413-096. ANALYSIS OF THE RETURNED DEVICE CONSISTED OF A VISUAL AND FUNCTIONAL EVALUATION, AS WELL AS A DEVICE HISTORY REVIEW. OVERALL VISUAL AND FUNCTIONAL TESTING OF THE DEVICE DETERMINED THAT ALL DEVICE COMPONENTS WERE FOUND WITHIN SPECIFICATION AND THE DHR REVIEW INDICATES THAT THE DEVICE WAS PROPERLY ASSEMBLED TO DESIGN AND MANUFACTURING SPECIFICATIONS. THE VISUAL EXAMINATION FOUND THAT THE DEVICE WAS WELL-WORN AND DISCOLORED WITH WHAT APPEARS TO BE A THICK, MILKY SUBSTANCE THROUGHOUT THE LENGTH OF THE TUBING. MULTIPLE AREAS OF RECESSED DIMPLES WERE FOUND ALONG THE LENGTH OF THE TUBING, A PINHOLE TEAR HAD OCCURRED THROUGH THE FILL-LUMEN ALLOWING FOR RESIDUE TO BUILD THROUGHOUT THE LUMEN, AND AREAS OF BULGING WERE NOTICED THROUGHOUT SEVERAL SECTIONS OF THE TUBING. THE CAUSE FOR THE SEPARATING TUBING SUPPORT IS BELIEVED TO BE RELATED TO THE COMBINATION OF EXCESSIVE CLOGGING AND DE-CLOGGING EPISODES, FUNGAL GROWTH, AND POSSIBLY DUE TO EXCESSIVE PRESSURE EXERTED THROUGH THE TUBING TO REMOVE THE CLOGS. THE EXAMINATION DETERMINED THAT THE REPORTED INCIDENT IS AN ISOLATED EVENT AND IS NOT BELIEVED TO HAVE RESULTED FROM A MANUFACTURING DEFECT. WE HAVE ASSIGNED COMPLAINT (B)(4) TO THIS REPORT.

    Description of Event or Problem · 1

    AS REPORTED: THE GJ TUBE WAS IN PLACE FOR ABOUT 7 MONTHS. THERE WERE 25 SEPARATE CLOGGING EPISODES THROUGHOUT USAGE THAT REQUIRED FLUSHING WITH A SYRINGE. THE TUBE RELEASED ITS INTERNAL TUBING SUPPORT INSIDE THE PATIENT. THE ENTIRE TUBING SUPPORT WAS REMOVED AT HOME WITH NO KNOWN HARM TO THE PATIENT. THE PATIENT WAS TAKEN TO THE HOSPITAL TO REPLACE THE GJ TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461718 AMT G-JET LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING DEVICE KNT APPLIED MEDICAL TECHNOLOGY, INC. 160413-096

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR