BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD SNARE RETREIVAL KIT

    MDR report key: 17279936 · Received July 7, 2023

    Report

    Report Number
    3008988055-2023-00006
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 16, 2023
    Report Date
    June 23, 2023
    Manufacturer
    HERAEUS MEDICAL COMPONENTS, LLC
    Product Code
    MMX
    UDI-DI
    00857834006544
    PMA / PMN Number
    K152560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT THE DEVICE HAS MALFUNCTIONED OR THAT THE DEVICE WAS RELATED TO A DEATH OR INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SNARE RETRIEVAL PROCEDURE, DEVICE ALLEGEDLY BROKEN INSIDE THE PATIENT. IT WAS FURTHER REPORTED THAT THE BROKEN PIECES WERE RETRIEVED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2015457 BARD SNARE RETREIVAL KIT DEVICE, PERCUTANEOUS RETRIEVAL MMX HERAEUS MEDICAL COMPONENTS, LLC SRK30 PL06295 00857834006544

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention