BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASIX COMPAK INFLATION SYRINGE KIT

    MDR report key: 2417283 · Received December 15, 2011

    Report

    Report Number
    9616662-2011-00071
    Event Type
    Malfunction
    Date Received
    December 15, 2011
    Date of Event
    November 21, 2011
    Report Date
    November 21, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K884913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVAL. THE USER DID NOT SPECIFY IF THIS WAS THE INITIAL USE OF THE DEVICE. THE USER WAS NO CERTAIN WHICH LOT THE SUSPECT DEVICE CAME FROM BUT REPORTED THE FOLLOWING THREE POSSIBLE LOT NUMBERS: K295314 - EXP DATE: 09/30/2014. DEVICE MANUFACTURE DATE: 10/2011. K292880 - EXP DATE: 09/30/2014. DEVICE MANUFACTURE DATE: 10/2011. K287855 - EXP DATE: 09/30/2014. DEVICE MANUFACTURE DATE: 10/2011. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING AN ANGIOGRAPHIC PROCEDURE THE GAUGE ON THE INFLATION DEVICE WOULD NOT SHOW THE CORRECT PRESSURE. IT WAS CONFIRMED HOWEVER THAT THE BALLOON HAD BEEN INFLATED. THE PHYSICIAN THEN EXCHANGED THE DEVICE AND EXPERIENCED THE SAME FAILURE. NO HARM OR INJURY WAS REPORTED. THIS IS ONE OF TWO REPORTS FOR THIS COMPLAINT - 9616662-2011-00070.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA| BALLOON