BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASIX COMPAK INFLATION SYRINGE

    MDR report key: 2154912 · Received June 27, 2011

    Report

    Report Number
    9616662-2011-00041
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    April 28, 2011
    Report Date
    June 3, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K884913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: OTHER, THE EVALUATION HAS NOT BEEN COMPLETED. THE CUSTOMER REPORTED THAT THE SUSPECT DEVICE COULD HAVE ALSO COME FROM LOT K213179. EXPIRATION DATE: 01/31/2014. DEVICE MANUFACTURE DATE: 02/2011. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED. EVALUATION: CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL STENTING PROCEDURE THAT THE NEEDLE IN THE PRESSURE GAUGE MOVED BACKWARDS AND COULD NOT HOLD PRESSURE ON THE FOURTH OR FIFTH INFLATION. THE CUSTOMER DID NOT KNOW AT WHAT PRESSURE THE FAILURE OCCURRED. AFTER A VISUAL EXAMINATION, A LEAK WAS OBSERVED AT THE CONNECTION BETWEEN THE GAUGE AND THE BARREL. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASIX COMPAK INFLATION SYRINGE INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT MERIT MEDICAL SYSTEMS, INC. K197886

    Patients

    Seq Age Sex Outcome Treatment
    1 CATHETER| CONTRAST MEDIA| SALINE