BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    50-13172 SPECIAL PROCEDURE TRAY #6957

    MDR report key: 316458 · Received February 12, 2001

    Report

    Report Number
    316458
    Event Type
    Malfunction
    Date Received
    February 12, 2001
    Date of Event
    January 5, 2001
    Report Date
    February 9, 2001
    Manufacturer
    DEROYAL INC.
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CLAIMS THAT A TECH, PREPARING FOR AN ARTERIOGRAM PROCEDURE, NOTICED A HOLE ON THE SIDE OF THE BARREL OF THE 10CC SYRINGE THAT IS CONTAINED INSIDE OF THIS TRAY LEAKED. ACCORDING TO REPORTER, THE SYRINGE WAS DISCARDED. NO INJURY OR EXPOSURE TO PT OR TECH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5256 50-13172 SPECIAL PROCEDURE TRAY #6957 CTG CUSTOM PROCEDURAL TRAY GENERAL LRO DEROYAL INC. 2 543415

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN