BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNT TUBES, GASTROINTESTINAL

    MDR report key: 6678899 · Received June 29, 2017

    Report

    Report Number
    1820334-2017-01781
    Event Type
    Malfunction
    Date Received
    June 29, 2017
    Date of Event
    April 24, 2017
    Report Date
    October 23, 2017
    Manufacturer
    COOK INC
    Product Code
    KNT
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF THE DRAWING, MANUFACTURING INSTRUCTIONS, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL DATA WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, DEVICE FAILURE ANALYSIS AND PHYSICAL EXAMINATION OF THE DEVICE USED IN THIS CASE COULD NOT BE PERFORMED. DURING THE MANUFACTURING PROCESS THE CAP IS PULLED OVER FLARE UNTIL FLARE IS SEATED AGAINST INSIDE BOTTOM OF CAP. THE ADAPTER IS THEN ATTACHED TO THE CAP AND ADHESIVE IS APPLIED TO THE THREADS OF THE ADAPTER TO PREVENT THE CAP AND ADAPTOR FROM REVERSE THREADING AFTER ASSEMBLY. THE PROCESS VALIDATION WAS PERFORMED FOR THE ATTACHMENT OF THE PROXIMAL HUBS TO THE CATHETER. ACCEPTANCE CRITERIA OF 15N TENSILE LOAD WAS MET FOR BOTH DISTAL AND PROXIMAL GJS CONNECTIONS. THE TEST DATA CONFIRMED THAT THE TENSILE FORCE TO SEPARATE THE HUB FROM THE SHAFT EXCEEDS THE ACCEPTANCE CRITERIA OF = 15N (3.3LBS). THE PRODUCT MANUFACTURING RECORD WAS ASSESSED AND NO NOTABLE GAPS IN THE PRODUCTION OR PROCESSING CONTROLS WERE OBSERVED. AS A PREVENTIVE MEASURE, INTERNAL PERSONNEL WERE RETRAINED TO INTERNAL QUALITY CONTROL INSPECTION AND MANUFACTURING PROCEDURES AS WELL AS ADVISED OF THE RISKS ASSOCIATED WITH HUB FAILURE FOR THIS DEVICE. THE DEVICE INSTRUCTIONS FOR USE (IFU) DETAILS THE INSTRUCTIONS FOR USE, INCLUDING HOW TO HANDLE THE DEVICE DURING FORMATION OF THE MALECOT DURING PLACEMENT OF THE DEVICE. MEDICAL PERSONNEL AT SCRIPPS MERCY HOSPITAL WERE RETRAINED ON THE PROPER WAY TO PLACE THE FEEDING TUBE AND FORM THE MALECOT PER THE IFU. BASED ON THE AVAILABLE INFORMATION, IT IS NOT CLEAR IF THE LEADING CAUSE TO THIS EVENT MIGHT BE ASSOCIATED WITH THE MOBILIZATION OF THE PATIENT (THE CAP COULD BECOME DISLODGED DURING THE MOBILIZATION OF THE PATIENT), AN EVENTUAL MEDICAL PROCEDURE EVENT OR AN EVENTUAL MALFUNCTION OF THE DEVICE. THEREFORE, THE ROOT CAUSE OF THIS EVENT CANNOT BE ESTABLISHED OR REPORTED AT THIS TIME. MEASURES HAVE BEEN PREVIOUSLY INITIATED TO ADDRESS THIS ISSUE. WE WILL NOTIFY THE APPROPRIATE PERSONNEL AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    ULTRATHANE CAREY-ALZATE-COONS GASTROJEJUNOSTOMY REPLACEMENT CATHETER. THIS EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE GENERATED UPON THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT REQUIRED REPLACEMENT OF ULTRATHANE CAREY-ALZATE-COONS GASTROJEJUNOSTOMY REPLACEMENT CATHETER. THE RED FITTING WAS ALLEGED TO HAVE FRACTURED. NO INFORMATION HAS BEEN PROVIDED CONCERNING THE MAINTENANCE OF THE DEVICE, OR THE CIRCUMSTANCES ASSOCIATED WITH THE HANDLING OF THE DEVICE. AN INVESTIGATION HAS BEEN OPENED TO ASSESS THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458930 KNT TUBES, GASTROINTESTINAL KNT COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR