BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASIX COMPAK INFLATION SYRINGE

    MDR report key: 2419074 · Received December 21, 2011

    Report

    Report Number
    9616662-2011-00073
    Event Type
    Malfunction
    Date Received
    December 21, 2011
    Date of Event
    December 2, 2011
    Report Date
    December 2, 2011
    Manufacturer
    MERIT MEDICAL SYSTEM, INC
    Product Code
    DXT
    PMA / PMN Number
    K884913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 REPORTED A SECOND POSSIBLE LOT NUMBER FOR THE SUSPECT DEVICE: K284755, EXPIRATION DATE - 08/31/2014, DEVICE MFR DATE - 09/01/2011. A F/U 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 MALFUNCTIONED. THE USER REPORTED THAT THE BALLOON INFLATED, BUT WHILE INFLATING THE GAUGE GOT STUCK AT 2ATM THEN JUMPED TO 10ATM. THE USER REPORTED THREE DEFECTIVE DEVICES. NO HARM OR INJURY WAS REPORTED. THIS IS ONE OF THREE REPORTS FOR THIS COMPLAINT. 9616662-2011-00073 - THIS REPORT, 9616662-2011-00074, 9616662-2011-00075.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASIX COMPAK INFLATION SYRINGE INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT MERIT MEDICAL SYSTEM, INC K281582

    Patients

    Seq Age Sex Outcome Treatment
    1 ANGIOGRAPHY BALLOON