BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION ARTICULATING STONE BASKET/GRASPER

    MDR report key: 4137560 · Received September 26, 2014

    Report

    Report Number
    1018233-2014-00258
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 24, 2014
    Manufacturer
    OMNITECH SYSTEMS, INC.
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS NOT ASSOCIATED WITH A CUSTOMER COMPLAINT OR REPORTED ADVERSE EVENT; HOWEVER, IT IS BEING FILED IN ACCORDANCE WITH 21 CFR PART 803.53. THE INVESTIGATION IS STILL IN PROGRESS UNDER INVESTIGATION NUMBER (B)(4). ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    BARD MEDICAL DIVISION HAS CONFIRMED 96 UNITS OF LOT BMXJM031 WERE SHIPPED TO CUSTOMERS AS NON-STERILE (WITHOUT STERILIZATION). THIS WAS DISCOVERED DURING A REVIEW OF INTERNAL PROCESS. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600172 DIMENSION ARTICULATING STONE BASKET/GRASPER FFL OMNITECH SYSTEMS, INC. NA BMXJM031

    Patients

    Seq Age Sex Outcome Treatment
    1