BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW SAC-02318-PBX

    MDR report key: 10017574 · Received May 1, 2020

    Report

    Report Number
    3006425876-2020-00395
    Event Type
    Malfunction
    Date Received
    May 1, 2020
    Date of Event
    December 25, 2019
    Report Date
    April 16, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K171146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER; THEREFORE, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED UPON A LOT NUMBER FROM THE SALES HISTORY DATA OF THE CUSTOMER. NO RELEVANT FINDINGS WERE IDENTIFIED. 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS: THE WIRE KINKED DURING INSERTION. THE REPORTED DEFECT WAS DETECTED DURING USE. THE PATIENT CONDITION IS REPORTED AS "FINE". THERE WAS NO PATIENT COMPLICATION, INJURY OR CONSEQUENCE AS A RESULT OF THE REPORTED DEVICE ISSUE. IT IS UNKNOWN IF THERAPY WAS DELAYED/INTERRUPTED.

    Additional Manufacturer Narrative · 1

    (B)(4). POTENTIAL LOT# 71F19D1365.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS: THE WIRE KINKED DURING INSERTION. THE REPORTED DEFECT WAS DETECTED DURING USE. THE PATIENT CONDITION IS REPORTED AS "FINE". THERE WAS NO PATIENT COMPLICATION, INJURY OR CONSEQUENCE AS A RESULT OF THE REPORTED DEVICE ISSUE. IT IS UNKNOWN IF THERAPY WAS DELAYED/INTERRUPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481664 ARROW SAC-02318-PBX CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1