BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL CATH SET: 20GA X 5CM

    MDR report key: 3960121 · Received June 23, 2014

    Report

    Report Number
    3006425876-2014-00134
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K810675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE PACKAGING IS TOO THIN, CONSEQUENTLY THE SWG IS INSUFFICIENTLY PROTECTED DURING STORAGE AND IS EXPOSED TO KINDS. WHEN THE PACKAGING IS OPENED, THE SWG IS KINKED AT 3CM OF THE DISTAL TIP, SO IT IS UNUSABLE. THE PATIENT NEEDED TO BE RE-PUNCTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364759 ARTERIAL CATH SET: 20GA X 5CM ARTERIAL CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC. 71F14A1189

    Patients

    Seq Age Sex Outcome Treatment
    1