BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC KIT: 5-LUMEN 8.5FR X 16CM

    MDR report key: 13839982 · Received March 21, 2022

    Report

    Report Number
    3006425876-2022-00240
    Event Type
    Malfunction
    Date Received
    March 21, 2022
    Date of Event
    February 26, 2022
    Report Date
    February 28, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    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

    QN# (B)(4). COMPLAINT VERIFICATION TESTING 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 14P21C0042 AND 14P21C0244 FOR POTENTIAL ISSUES WITH DRYING DURING SUPPLIER MANUFACTURING. 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. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT REPORTED A CRACKED NEEDLE HUB. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT REPORTED A CRACKED NEEDLE HUB. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547630 ARROW CVC KIT: 5-LUMEN 8.5FR X 16CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL LLC 71F21F1591

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Unknown