BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW ARTERIAL CATH SET: 20GA X 8CM

    MDR report key: 18357753 · Received December 19, 2023

    Report

    Report Number
    3006425876-2023-01262
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    September 12, 2023
    Report Date
    November 24, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    UDI-DI
    10801902144079
    PMA / PMN Number
    K093050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER REPORT OF A KINKED GUIDE WIRE PRIOR TO USE WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. ONE KINK WAS OBSERVED ON THE GUIDE WIRE BODY. IN ADDITION, SEVERAL FOLDS AND CREASES WERE OBSERVED ON THE OUTSIDE PACKAGING. THE GUIDE WIRE MET ALL RELEVANT DIMENSIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. THE LIDSTOCK CLEARLY STATES "DO NOT BEND." BASED ON THE CUSTOMER DESCRIPTION AND THE SAMPLE RECEIVED, STORAGE AND SHIPPING CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4). IN SECTION D PROVIDED THE FULL UDI # **UDI RELATED DATA QUALITY UPDATES ONLY** OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT " WHEN OPENING THE PAM CATHETER, THE DAMAGED GUIDE WIRE WAS IDENTIFIED, ALREADY CROOKED INSIDE THE PROTECTIVE COVER. MAKING IT IMPOSSIBLE TO USE FOR PASSAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT " WHEN OPENING THE PAM CATHETER, THE DAMAGED GUIDE WIRE WAS IDENTIFIED, ALREADY CROOKED INSIDE THE PROTECTIVE COVER. MAKING IT IMPOSSIBLE TO USE FOR PASSAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT " WHEN OPENING THE PAM CATHETER, THE DAMAGED GUIDE WIRE WAS IDENTIFIED, ALREADY CROOKED INSIDE THE PROTECTIVE COVER. MAKING IT IMPOSSIBLE TO USE FOR PASSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497656 ARROW ARTERIAL CATH SET: 20GA X 8CM CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL LLC 71F22F4956 10801902144079

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown