BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI KIT: 9 FR

    MDR report key: 4102429 · Received August 27, 2014

    Report

    Report Number
    3006425876-2014-00189
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 22, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DYB
    PMA / PMN Number
    K780532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT NUMBER IS NOT SOLD WITHIN THE USA. HOWEVER, SIMILAR PRODUCTS WITH THE SAME DILATOR ARE SOLD WITHIN THE USA. THE 510(K) NUMBER GIVEN IS FOR PRODUCT SOLD WITHIN THE USA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE OPERATING ROOM WHEN THE ANESTHESIOLOGIST WAS REMOVING THE DILATOR FROM THE PATIENT'S RIGHT INTERNAL JUGULAR VEIN, THE TIP OF THE DILATOR WAS FOUND HEAVILY DEFORMED. AS A RESULT, A NEW KIT WAS OPENED AND USED WITHOUT ISSUE. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518988 PSI KIT: 9 FR CRITICAL CARE PSI PRODUCTS DYB ARROW INTERNATIONAL INC. 71F14D1191

    Patients

    Seq Age Sex Outcome Treatment
    1