BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 CM

    MDR report key: 8812650 · Received July 22, 2019

    Report

    Report Number
    1036844-2019-00861
    Event Type
    Malfunction
    Date Received
    July 22, 2019
    Date of Event
    July 3, 2019
    Report Date
    July 5, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    MSD
    PMA / PMN Number
    K111117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE HEMODIALYSIS CATHETER, LIDSTOCK AND OTHER VARIOUS COMPONENTS FOR EVALUATION. THE ARTERIAL EXTENSION LINE WAS SEPARATED NEAR THE LUER HUB. MICROSCOPIC EXAMINATION REVEALED THE POINT OF SEPARATION IS JAGGED, INDICATING UNDUE FORCE CAUSED THE BREAKAGE. A PORTION OF TUBING WAS ALSO FOUND IN THE LUER HUB. THIS MATERIAL ALSO APPEARED ROUGH AND JAGGED. THERE WAS ALSO A CRACK OBSERVED IN THE LUER HUB. NONE OF THE OTHER COMPONENTS LOOKED TO BE USED. THE OUTER DIAMETER OF THE EXTENSION LINE MEASURED .189" WHICH IS WITHIN SPECIFICATION OF .185-.191" PER PRODUCT DRAWING. THE INNER DIAMETER OF THE EXTENSION LINE MEASURED .124" WHICH IS WITHIN SPECIFICATION OF .120-.126" PER PRODUCT DRAWING. A MANUAL TUG TEST CONFIRMED THE VENOUS EXTENSION LINE WAS PROPERLY SECURED WITHIN THE LUER HUB. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. THE IFU PROVIDED WITH THIS KIT WARNS THE USER "DO NOT APPLY EXCESSIVE FORCE IN PLACING OR REMOVING CATHETER. EXCESSIVE FORCE CAN CAUSE CATHETER BREAKAGE. IF PLACEMENT OR WITHDRAWAL CANNOT BE EASILY ACCOMPLISHED, AN X-RAY SHOULD BE OBTAINED AND FURTHER CONSULTATION REQUESTED". THE CUSTOMER REPORT OF EXTENSION LINE SEPARATION WAS CONFIRMED BY COMPLAINT INVESTIGATION. THE RETURNED ARTERIAL EXTENSION LINE WAS SEPARATED AND THE EDGES WERE ROUGH AND JAGGED, INDICATING UNDUE FORCE CAUSED THE BREAKAGE. THERE WAS ALSO A CRACK LOCATED IN THE LUER HUB. THE RETURNED SAMPLE PASSED ALL RELEVANT DIMENSIONAL INSPECTION AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. BASED ON THE SAMPLE RETURNED, UNINTENTIONAL USE ERROR LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THAT THE DOCTOR FOUND THE JUNCTURE HUB WAS BROKEN DURING USAGE.

    Additional Manufacturer Narrative · 1

    (B)(4). PRELIMINARY EVALUATION OF THE RETURNED DEVICE INDICATES THE EXTENSION LINE SEPARATED/TORN DURING USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE DOCTOR FOUND THE JUNCTURE HUB WAS BROKEN DURING USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605478 ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 CM CATHETER, HEMODIALYSIS, IMPLA MSD ARROW INTERNATIONAL INC. 23F18E0190

    Patients

    Seq Age Sex Outcome Treatment
    1