BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNT TUBES, GASTROINTESTINAL

    MDR report key: 5612203 · Received April 27, 2016

    Report

    Report Number
    1820334-2016-00211
    Event Type
    Injury
    Date Received
    April 27, 2016
    Date of Event
    March 15, 2016
    Report Date
    April 4, 2016
    Manufacturer
    COOK INC
    Product Code
    KNT
    UDI-DI
    00827002084179
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT. IDENTIFIER) REQUESTED BUT NOT PROVIDED. AGE AT TIME OF EVENT, DATE OF BIRTH) REQUESTED BUT NOT PROVIDED. WEIGHT) REQUESTED BUT NOT PROVIDED. ULTRATHANE WILLS-OGLESBY SINGLE LUMEN MALLINCKRODT INST MODIFICATION GASTROSTOMY SET. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF COMPLAINT HISTORY, DEVICE RECORD HISTORY, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, DRAWINGS, QUALITY CONTROL,TRENDS AND VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE DEVICE IS SHIPPED WITH IFU THAT DESCRIBES THE INTENDED USE, SPECIFIC ITEMS ARE ADDRESSED SUCH AS WARNINGS, PRECAUTIONS AND INSTRUCTIONS FOR PLACEMENT AND USE OF THE DEVICE. THE MANUFACTURING RECORD FOR THIS LOT WAS REVIEWED, AND NOTHING OF NOTE WAS OBSERVED. IT SHOULD BE NOTED THAT THERE ARE NO OTHER COMPLAINTS OF ANY NATURE ASSOCIATED WITH THIS LOT. THE VISUAL EXAMINATION REPORTED THE RETURNED DEVICE WAS IN TWO PIECES. THE HUB AND COOK COPE LOCKING MECHANISM HAD BEEN CUT FROM THE PROXIMAL PORTION OF THE SHAFT AND WERE NOT RETURNED. THE DISTAL PORTION SHOWED THE SIDEPORTS TO BE PRODUCED TO SPECIFICATION BOTH IN SIZE AND ALIGNMENT. THE TWO PIECES WERE SEPARATED AND THE SHAFT HAD INFLATED AT THE SEPARATION POINT. WE ATTEMPTED TO PASS A COOK 0.035 WIRE GUIDE THROUGH BOTH PORTIONS OF THE CATHETER AND WERE ABLE TO PASS THE WIRE GUIDE THROUGH THE SECTIONS OF THE TUBE SUCCESSFULLY. THE INVESTIGATION WAS ABLE TO MOCK UP A CATHETER CONNECTED TO A SYRINGE AT THE PROXIMAL HUB AND CLAMP THE DISTAL END OF THE DEVICE WITH A HEMOSTAT. WE WERE ABLE TO DUPLICATE THE REPORTED EVENT. BASED ON EXAMINATION OF THE RETURNED DEVICE AND PREVIOUSLY CONDUCTED EXPERIMENTS, IT IS REASONABLE TO SUGGEST THAT THE DRAINAGE HAD STOPPED DUE TO OCCLUSION OF THE DEVICE. IN THE ATTEMPT TO CLEAR THE OBSTRUCTION, THE CATHETER WAS BROKEN AND THEN HAD TO BE EXCHANGED AND REPLACED BY THE PHYSICIAN. ROOT CAUSE WAS DETERMINED TO BE RELATED TO USE AND PRODUCT HANDLING. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE MALE PATIENT EXPERIENCED DIFFICULTY WHEN HIS G-TUBE WAS NOT WORKING. THE PHYSICIAN PLACED A GUIDE TO DO AN EXCHANGE/OVER THE WIRE, AND NOTED THAT THE TUBE WAS COMPLETELY BROKEN ABOUT 2 INCHES FROM THE DISTAL END OF THE TUBE. THE CATHETER LOOKED LIKE IT HAD EXPLODED, AS IT HAD COMPLETELY SEPARATED WHILE IN THE PATIENT. A RETRIEVAL SET WAS USED TO RETRIEVE THE DISTAL PORTION OF THE CATHETER AND NO HARM WAS REPORTED TO THE PATIENT. ANOTHER G TUBE WAS PLACED.

    Description of Event or Problem · 1

    THE MALE PATIENT EXPERIENCED DIFFICULTY WHEN HIS G-TUBE WAS NOT WORKING. THE PHYSICIAN PLACED A GUIDE TO DO AN EXCHANGE/OVER THE WIRE, AND NOTED THAT THE TUBE WAS COMPLETELY BROKEN ABOUT 2 INCHES FROM THE DISTAL END OF THE TUBE. THE CATHETER LOOKED LIKE IT HAD EXPLODED, AS IT HAD COMPLETELY SEPARATED WHILE IN THE PATIENT. A RETRIEVAL SET WAS USED TO RETRIEVE THE DISTAL PORTION OF THE CATHETER AND NO HARM WAS REPORTED TO THE PATIENT. ANOTHER G TUBE WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267699 KNT TUBES, GASTROINTESTINAL KNT COOK INC NA 00827002084179

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention