BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 3-LUMEN 12 FR X 20 CM

    MDR report key: 13893186 · Received March 24, 2022

    Report

    Report Number
    3006425876-2022-00254
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    March 1, 2022
    Report Date
    March 3, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    PMA / PMN Number
    K970864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE ACTUAL DEVICE WAS NOT RETURNED; HOWEVER, THE CUSTOMER PROVIDED ONE PHOTO FOR ANALYSIS. THE COMPLAINT OF NEEDLE HUB CRACKED WAS ABLE TO BE CONFIRMED BY THE PHOTO. A COMPLETE VISUAL INSPECTION COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH ONE RELEVANT FINDING. A NON-CONFORMANCE WAS INITIATED FOR MATERIAL K-04300-019C, LOTS 14P21C0248 AND 14P21C0043 IN REGARD TO NEEDLE HUB CRACKED. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT STATES, "ARROW RAULERSON SYRINGE IS USED IN CONJUNCTION WITH ARROW ADVANCER FOR GUIDEWIRE INSERTION. INSERT INTRODUCER NEEDLE OR CATHETER/NEEDLE WITH ATTACHED SYRINGE OR ARROW RAULERSON SYRINGE (WHERE PROVIDED) INTO VEIN AND ASPIRATE." WITHOUT THE DEVICE TO EVALUATE, THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS A CRACK IN THE HUB OF THE NEEDLE AND THE USER WAS NOT ABLE TO ASPIRATE EFFECTIVELY. A NEW DEVICE WAS USED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS A CRACK IN THE HUB OF THE NEEDLE AND THE USER WAS NOT ABLE TO ASPIRATE EFFECTIVELY. A NEW DEVICE WAS USED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337807 ARROW CVC SET: 3-LUMEN 12 FR X 20 CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL LLC 71F21F0747

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown