BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY

    MDR report key: 7578904 · Received June 7, 2018

    Report

    Report Number
    1820334-2018-01662
    Event Type
    Injury
    Date Received
    June 7, 2018
    Date of Event
    May 15, 2018
    Report Date
    September 11, 2018
    Manufacturer
    COOK INC
    Product Code
    MPB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, TRENDS AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE NO PHYSICAL EXAMINATION COULD BE PERFORMED. A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER FOR THE DEVICE WAS NOT AVAILABLE. A COMPLAINT HISTORY SEARCH WAS ALSO UNABLE TO BE PERFORMED DUE TO THE LACK OF A LOT NUMBER. ROOT CAUSE IS INCONCLUSIVE. AT THIS TIME, WE CANNOT ELIMINATE ANY POSSIBLE CAUSES FOR THE CRACKED HUB SUCH AS PRODUCT HANDLING, PATIENT BEHAVIOR, PATIENT ENVIRONMENT, DEVICE STORAGE CONDITIONS, CATHETER MAINTENANCE/CARE, DEVICE FAILURE, OR MANUFACTURING RELATED CAUSES. PER THE [QUALITY ENGINEERING] RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. MONITORING WILL CONTINUE TO BE PERFORMED 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 WAS REPORTED SINCE THE SUBMISSION OF THE INITIAL REPORT ON 06/07/2018.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: MPB. (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 A COOK TURBO-FLO HD HEMODIALYSIS CATHETER HUB WAS CRACKED. THE DEVICE WAS IMPLANTED ON (B)(6) 2018 AND FOUND TO BE LEAKING FROM THE HUB LATER THAT EVENING WHEN A DIALYSIS TREATMENT (CRRT) WAS INITIATED. AS REPORTED, THE CATHETER HAD NOT BEEN ACCESSED BETWEEN IMPLANTATION. A NEW PROCEDURE WAS REQUIRED TO REMOVE AND REPLACE THE DEVICE. THE DEVICE WAS DISCARDED, HOWEVER, THE NURSE STATED THE VISUALIZED CRACK TO BE APPROXIMATELY 0.4 CM IN THE BLUE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420652 COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY MPB COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention