BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET

    MDR report key: 6325304 · Received February 13, 2017

    Report

    Report Number
    1820334-2017-00067
    Event Type
    Injury
    Date Received
    February 13, 2017
    Date of Event
    January 12, 2017
    Report Date
    June 1, 2017
    Manufacturer
    COOK INC
    Product Code
    MPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME) MPB. (B)(4). PMA#) K122091. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF THE DRAWINGS, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL WAS 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. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, IT IS REASONABLE TO SUGGEST THAT THE LEADING CAUSE OF THIS EVENT MAY BE ASSOCIATED WITH ROUGH HANDLING OF THE PRODUCT DURING THE MEDICAL PROCEDURE HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WITH A PREVIOUSLY IMPLANTED HEMODIALYSIS CATHETER WAS BEING ROLLED INTO BED BY A NURSE AND AN ATTENDING HEALTH CARE ASSOCIATE. ALL CATHETER LINES WERE REPORTEDLY CHECKED PRIOR TO ANY MOVEMENT. THE PATIENT WAS THEN ROLLED ONTO HER BACK AT WHICH TIME IT WAS NOTICED THAT THE HEMODIALYSIS CATHETER CAME LOOSE OF ITS SUTURE HUB AND WAS EXITING THE INSERTION SITE OF THE PATIENT. THE RESULTING BLEEDING WAS CONTROLLED BY COMPRESSION AT THE SITE. FURTHER INSPECTION BY THE REPORTING NURSE INDICATES THAT THE SUTURE HUB REMAINED SUTURED TO THE PATIENT AND THE CATHETER HAD 'SLIPPED FROM UNDER THE SUTURE PLATE.' THE DEVICE DID NOT FRACTURE, ACCORDINGLY NO UNINTENDED FOREIGN BODY WAS RETAINED WITHIN THE PATIENT'S BODY. BLEEDING WAS CONTROLLED AND A NEW CATHETER WAS PLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107706 COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET MPB COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention