BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNT TUBES, GASTROINTESTINAL

    MDR report key: 6683460 · Received July 1, 2017

    Report

    Report Number
    1820334-2017-01780
    Event Type
    Malfunction
    Date Received
    July 1, 2017
    Date of Event
    May 4, 2017
    Report Date
    November 3, 2017
    Manufacturer
    COOK INC
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDSUN REPORT #(B)(4) HAS BEEN ATTACHED TO THIS FOLLOW-UP MDR. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, DEVICE FAILURE ANALYSIS AND PHYSICAL EXAMINATION OF THE DEVICE USED IN THIS CASE COULD NOT BE PERFORMED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE COMPLAINT LOT NUMBER WAS NOT PROVIDED. A REVIEW OF THE WORK ORDER FOR NON-CONFORMANCES ALSO COULD NOT BE CONDUCTED. LIKEWISE, A SEARCH FOR SIMILAR COMPLAINTS FOR THIS LOT NUMBER COULD NOT BE CONDUCTED. 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. PROCESS VALIDATION ACTIVITIES HAVE SUCCESSFULLY BEEN COMPLETED FOR THIS PROCESS, WHICH CONSIDERED TENSILE PROPERTIES OF THE PROXIMAL FITTINGS AGAINST PREDETERMINED ACCEPTANCE CRITERIA. THE REVIEW OF THE DMR DID NOT OBSERVE ANY NOTABLE GAPS IN PRODUCTION AND PROCESSING CONTROLS NOTED. 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. 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. THIS COMPLAINT EVENT OCCURRED (B)(6) 2017. MEDICAL PERSONNEL AT (B)(6) HOSPITAL WERE RETRAINED ON THE PROPER WAY TO PLACE THE FEEDING TUBE AND FORM THE MALECOT PER THE IFU ON (B)(6) 2017. WE WILL NOTIFY THE APPROPRIATE PERSONNEL AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. MEASURES HAVE BEEN PREVIOUSLY INITIATED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    DEVICE NAME: ULTRATHANE CAREY-ALZATE-COONS GASTROJEJUNOSTOMY REPLACEMENT CATHETER.(B)(4). 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

    AS INDICATED IN A VOLUNTARY MEDWATCH REPORT, RED CAP AT THE END OF THE GTUBE CAME APART FROM THE TUBE, RESULTING IN THE PATIENT REQUIRING A NEW A NEW GTUBE TO BE PLACED. PRODUCT IN THE COMPLAINT WAS AN ULTRATHANE CAREY-ALZATE-COONS GASTROJEJUNOSTOMY REPLACEMENT CATHETER. AN INVESTIGATION HAS BEEN OPENED TO ASSESS THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463945 KNT TUBES, GASTROINTESTINAL KNT COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR