BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM ANTE

    MDR report key: 11466204 · Received March 11, 2021

    Report

    Report Number
    1036844-2021-00042
    Event Type
    Malfunction
    Date Received
    March 11, 2021
    Date of Event
    February 20, 2021
    Report Date
    February 25, 2021
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    MSD
    PMA / PMN Number
    K141051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER PROVIDED ONE IMAGE SHOWING A CHRONIC HEMODIALYSIS CATHETER WHILE INSIDE THE PATIENT. VISUAL ANALYSIS CONFIRMED THAT THE ARTERIAL EXTENSION LINE HAD SEPARATED. FURTHER ANALYSIS REVEALED THAT THE SEPARATION WAS LOCATED WHERE THE RED CLAMP HAD BEEN ACTIVATED ON THE EXTENSION LINE. THE CUSTOMER RETURNED ONE CHRONIC HEMODIALYSIS CATHETER FOR ANALYSIS. SIGNS-OF-USE IN THE FORM OF BIOLOGICAL MATERIAL WAS OBSERVED ON THE EXTENSION LINES. THE SEPARATED PORTION OF THE ARTERIAL EXTENSION LINE WAS NOT RETURNED. VISUAL ANALYSIS REVEALED THAT THE ARTERIAL EXTENSION LINE HAD SEPARATED AT APPROXIMATELY THE MIDDLE OF THE EXTRUSION. MICROSCOPIC EXAMINATION OF THE SEPARATION REVEALED THAT THE EXTENSION LINE APPEARED PINCHED. SUBSEQUENT DAMAGE WAS OBSERVED AT THE CORNERS OF THIS PINCHED SECTION. VISUAL ANALYSIS OF THE CATHETER CLAMP REVEALED THAT THE WHITE CLAMP INSERT THAT IS ATTACHED TO THE CLAMP AND CATHETER CONTAINED SEVERE SCRATCH MARKS AND WAS FRAYED. THESE SCRATCH MARKS CREATE A SHARP EDGE THAT COULD CAUSE THE SEPARATION. BASED ON THE APPEARANCE OF THESE SCRATCH MARKS, UNINTENTIONAL USER ERROR LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. THE POINT OF SEPARATION MEASURED 29MM FROM THE JUNCTURE HUB. THE EXTENSION LINE OUTER DIAMETER MEASURED .188", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .185"-.191" PER THE EXTENSION LINE EXTRUSION GRAPHIC. THE EXTENSION LINE INNER DIAMETER MEASURED .124", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .120"-.126" PER THE EXTENSION LINE EXTRUSION GRAPHIC. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "DO NOT USE SHARP INSTRUMENTS NEAR EXTENSION LINES OR CATHETER. DO NOT USE CLAMPS OTHER THAN THOSE THAT ARE PROVIDED. USING OTHER CLAMPS MAY DAMAGE THE CATHETER. DO NOT CLAMP TUBING REPEATEDLY IN THE SAME PLACE. DOING SO MAY WEAKEN THE TUBING". THE REPORT OF AN EXTENSION LINE SEPARATION WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL ANALYSIS REVEALED THAT THE ARTERIAL EXTENSION LINE WAS PINCHED AND SEPARATED. IN REFERENCE TO THE CUSTOMER SUPPLIED PHOTO, THE AREA OF THE SEPARATION APPEARS TO BE AT THE SAME LOCATION AS THE CATHETER CLAMP. ANALYSIS OF THE CATHETER CLAMP REVEALED SEVERE SCRATCH MARKS ON THE WHITE INSERT LOCATED BETWEEN THE EXTENSION LINE AND THE CLAMP. THIS DAMAGE LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. THE CATHETER MET ALL RELEVANT DIMENSIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. BASED ON THE CUSTOMER REPORT AND THE SAMPLE RECEIVED, UNINTENTIONAL USER ERROR LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: MALE PATIENT WITH CATHETERIZATION DONE ON 03-AUG-2020 AND HAS UNDERGONE DIALYSIS FOR 6 MONTHS. "FOUND LEAKAGE IN LUMENS NOW AND LUMEN BROKEN". THE DEVICE WAS REMOVED IN ITS ENTIRETY. THEARPY WAS DELAYED WITH NO COMPLICATIONS FOR THE PATIENT. THE PATIENT HAD TO UNDERGO ANOTHER CATHETERIZATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: MALE PATIENT WITH CATHETERIZATION DONE ON (B)(6) 2020 AND HAS UNDERGONE DIALYSIS FOR 6 MONTHS. "FOUND LEAKAGE IN LUMENS NOW AND LUMEN BROKEN". THE DEVICE WAS REMOVED IN ITS ENTIRETY. THEARPY WAS DELAYED WITH NO COMPLICATIONS FOR THE PATIENT. THE PATIENT HAD TO UNDERGO ANOTHER CATHETERIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360923 ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM ANTE CATHETER, HEMODIALYSIS, IMPLA MSD ARROW INTERNATIONAL INC. 23F19G0022

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEMODIALYSIS| HEMODIALYSIS