BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNT TUBES, GASTROINTESTINAL

    MDR report key: 8787017 · Received July 12, 2019

    Report

    Report Number
    1820334-2019-01654
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Report Date
    August 12, 2019
    Manufacturer
    COOK INC
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: A REVIEW OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND SPECIFICATIONS OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. AFTER ADDITIONAL INVESTIGATION INTO THE REPORTED PRODUCT, THE AFFECTED PRODUCT RPN WAS SUSPECTED TO BE ULT14.0-NT-63-P-3S-GJS-SHETTY. THE INVESTIGATION CONTINUED ON THIS ASSUMPTION. IT WAS CONCLUDED SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. NO ADDITIONAL DEVICES WERE ABLE TO BE PULLED FROM THE DISTRIBUTION CENTER FOR FURTHER TESTING, AND A DATABASE SEARCH FOR COMPLAINTS WAS UNABLE TO BE COMPLETED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE: PRODUCT INFORMATION CURRENTLY UNAVAILABLE. OCCUPATION: COMPLAINT ANALYST. PMA/510(K) #: PREAMENDMENT. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED AN UNSPECIFIED COOK SHETTY GASTROJEJUNOSTOMY CATHETER WAS USED TO DELIVER MEDICATION TO A PATIENT. PER THE REPORT, "THE PATIENT STATING HER CONNECTOR FROM THE CASSETTE TO THE J-PORT IS LEAKING, BUT SHE IS STILL INFUSING DUOPA (MEDICATION)." IT IS UNKNOWN IF THE PATIENT HAS HAD TUBE REPLACED OR SUFFERED ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579055 KNT TUBES, GASTROINTESTINAL KNT COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1