BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO-MATE

    MDR report key: 8457996 · Received March 27, 2019

    Report

    Report Number
    0001213649-2019-00001
    Event Type
    Malfunction
    Date Received
    March 27, 2019
    Date of Event
    February 14, 2019
    Report Date
    March 27, 2019
    Manufacturer
    CADENCE SCIENCE, INC.
    Product Code
    FMF
    UDI-DI
    00816329023404
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WILL BE COMPLETED UPON RECEIPT OF THE SYRINGES FROM THE USER. AT SUCH TIME WE WILL FOLLOW-UP AND UPDATE THE MDR WITH FINAL ACTIONS AND DETERMINATIONS.

    Description of Event or Problem · 1

    THE GLASS SYRINGE BROKE AT THE TOP FLANGE WHERE THE PRESSURE CONTROL RINGS ATTACH TO THE GLASS. THE CUSTOMER REPORTED THAT WHILE IN SURGERY, SCRUB TECH DREW UP LIDOCAINE AND HANDED THE GLASS SYRINGE TO THE SURGEON. THE SURGEON INJECTED THE PATIENT AND WHEN PRESSURE WAS APPLIED TO ADMINISTER THE MEDICATION, WHERE THE RINGS ATTACH TO THE VIAL "POPPED" APART. NO PATIENTS HAVE BEEN HARMED. THE SYRINGE ITSELF DOESN'T BREAK/SHATTER - THE RING THAT HAS THE 2 LOOPS BREAKS AWAY FROM THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247967 MICRO-MATE PRESSURE CONTROL SYRINGE FMF CADENCE SCIENCE, INC. 5340 W051186/1 00816329023404

    Patients

    Seq Age Sex Outcome Treatment
    1