BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5F MICRO-INTRODUCER SET

    MDR report key: 6098270 · Received November 13, 2016

    Report

    Report Number
    1625425-2016-00082
    Event Type
    Malfunction
    Date Received
    November 13, 2016
    Date of Event
    October 14, 2016
    Report Date
    November 13, 2016
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    DQO
    PMA / PMN Number
    ENFORCEMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE RETURNED BY THE CUSTOMER WAS EXAMINED UNDER LIGHTED MAGNIFICATION, AND VERIFIED THAT THE DILATOR WAS IN TWO PIECES. THERE IS NO EVIDENCE THAT THE TUBING WAS EVER PROPERLY OVER-MOLDED. THE TUBING WAS NOT FULLY PLACED ONTO THE OVER-MOLDING PIN PRIOR TO THE HUB BEING OVER-MOLDED IN PLACE. THE TUBING IS MANUALLY PLACED ON THE PIN PRIOR TO MOLDING. DETERMINED TO BE AN OPERATOR ERROR SINCE THE TUBING WAS NOT FULLY LOADED ONTO THE PIN PRIOR TO OVER-MOLDING. THE MOLDING SUPERVISOR AND MOLDING TECHNICIAN WERE INFORMED OF THE ISSUE AND SHOWED THE SAMPLES. ADDITIONALLY, SINCE A SIMILAR ISSUE HAS NOT OCCURRED OVER THE PAST YEAR, THIS ISSUE IS CONSIDERED AN ISOLATED INCIDENT. AFTER THE DILATOR HUB IS OVER-MOLDED ONTO THE TUBING, THE DILATORS UNDERGO A 100% NON-DESTRUCTION PULL TEST TO VERIFY THE HUB/TUBING INTERFACE. ADDITIONALLY, A SAMPLE SIZE FROM EACH LOT UNDERGOES A DESTRUCTIVE PULL TEST THAT MUST MEET A MINIMUM OF 3LBS.

    Description of Event or Problem · 1

    THE VESSEL DILATOR WAS LEFT IN PLACE. THE USER NOTICED THE ISSUE WHEN ONLY THE DILATOR HUB WAS LYING ON THE STERILE FIELD. THE REMAINING LENGTH OF THE DILATOR WAS NOT IN SIGHT BUT WAS LOCATED WITH ULTRASOUND IMAGING AND WAS REMOVED VIA AN APPROXIMATE 3 CM INCISION AND CLOSED WITH 5 SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749430 5F MICRO-INTRODUCER SET MICRO-INTRODUCER SET (DILATOR) DQO ARGON MEDICAL DEVICES INC. 11122663

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention