BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM

    MDR report key: 16147416 · Received January 12, 2023

    Report

    Report Number
    3006425876-2023-00096
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    January 20, 2022
    Report Date
    December 16, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    LFJ
    PMA / PMN Number
    K895417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH TWO FINDINGS. FOR MATERIAL 002200-014040 AND LOT 71C20H0946, A NON-CONFORMANCE WAS INITIATED FOR SMALLER INNER DIAMETER OF TUBES. FOR MATERIAL N5-04300-005A AND LOT 71P20L1281, A NON-CONFORMANCE WAS INITIATED FOR NEEDLE BENT. HOWEVER, THESE ARE NOT RELEVANT TO THIS COMPLAINT ISSUE AS THE REPORT DESCRIBES AN ISSUE WITH THE GUIDEWIRE. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: "NEPHROLOGY PHYSICIAN'S REPORT: PROBLEM WITH THE GUIDEWIRE THAT REQUIRED OPENING A NEW KIT TO COMPLETE THE PUNCTURE." NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: "NEPHROLOGY PHYSICIAN'S REPORT: PROBLEM WITH THE GUIDEWIRE THAT REQUIRED OPENING A NEW KIT TO COMPLETE THE PUNCTURE." NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391624 ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM CATHETER SUBCLAVIAN LFJ ARROW INTERNATIONAL LLC 71F21B1353

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NOT REPORTED| NOT REPORTED