BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEK RX PTA CATHETER

    MDR report key: 2976575 · Received January 28, 2013

    Report

    Report Number
    9616666-2013-00002
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    December 26, 2012
    Report Date
    January 2, 2013
    Manufacturer
    CLEAR STREAM TECHNOLOGIES, LTD.
    Product Code
    LIT
    PMA / PMN Number
    K072947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY IN PROGRESS. EVALUATED BY MANUFACTURER: THE SAMPLE EVALUATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POUCH WAS OPEN. THE OPEN POUCH WAS DISCOVERED IN DISTRIBUTION DURING AN ANNUAL INSPECTION. REPORTEDLY, THE POUCH SEAL WAS PARTIALLY OPENED. THE BOX WAS INTACT AND THERE WAS NO DAMAGE TO THE PRODUCT. THE PACKAGE WAS HANDLED NORMALLY AS PER CONSIGNMENT PROCEDURES. THE PRODUCT WAS NOT USED CLINICALLY AND WAS NOT RE-STERILISED OR REPACKAGED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38386 SLEEK RX PTA CATHETER LIT CLEAR STREAM TECHNOLOGIES, LTD. 50023755

    Patients

    Seq Age Sex Outcome Treatment
    1