BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY

    MDR report key: 7739880 · Received August 1, 2018

    Report

    Report Number
    1820334-2018-02259
    Event Type
    Injury
    Date Received
    August 1, 2018
    Report Date
    January 14, 2019
    Manufacturer
    COOK INC
    Product Code
    MPB
    UDI-DI
    00827002351097
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE REPORTED DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. INVESTIGATION: A DOCUMENT-BASED INVESTIGATION REVIEWED THE FOLLOWING: INSTRUCTIONS FOR USE, COMPLAINT HISTORY, DEVICE HISTORY RECORD AND QUALITY CONTROL SPECIFICATIONS. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. A REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT COULD CONTRIBUTE TO THIS FAILURE MODE. A COMPLAINT HISTORY SEARCH REVEALED THAT THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THEREFORE, THERE IS NO INDICATION FROM THE DEVICE HISTORY RECORD THAT THERE IS NONCONFORMING PRODUCT IN THE FIELD. RISK ASSESSMENT DETERMINED THAT RISK CONTROLS ARE IN PLACE TO MITIGATE THIS FAILURE MODE. THE APPROPRIATE PERSONNEL WERE NOTIFIED. APPROPRIATE MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. CONCLUSION: BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. 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 NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: MPB CATHETER, HEMODIALYSIS, NON-IMPLANTED. (B)(4). PMA/510(K) #: K161504. 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 THAT, AFTER INSERTION ON AN UNSPECIFIED DATE, THE HUB ON THE CATHETER IN A COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY WAS CRACKED AND BEGAN TO LEAK. THE CATHETER WAS REMOVED AND ANOTHER LINE WAS USED. TO DATE, ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT PROVIDED. AS REPORTED, THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE TO REMOVE AND REPLACE THE DEVICE, HOWEVER, THIS OCCURRENCE DID NOT CAUSE ANY OTHER ADVERSE EFFECTS ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581269 COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY MPB COOK INC NA 8582965 00827002351097

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention