BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOPLEX

    MDR report key: 11234659 · Received January 27, 2021

    Report

    Report Number
    9611612-2021-00002
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    January 20, 2021
    Report Date
    April 6, 2021
    Product Code
    BSP
    UDI-DI
    14048223017040
    PMA / PMN Number
    K111374
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT TOOK PLACE IN GERMANY. AS SOON AS FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY. BASED ON RISK ASSESSMENT AND CLINICAL ASSESSMENT THIS FILE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 0

    IRN# (B)(4). CANNULA BREAKAGE. PIECE REMAINED IN PATIENT. SURGICALLY REMOVED.

    Additional Manufacturer Narrative · 1

    EVENT TOOK PLACE IN (B)(6). AS SOON AS FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY.

    Description of Event or Problem · 1

    IRN# (B)(4). CANNULA BREAKAGE. PIECE REMAINED IN PATIENT. SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137034 SONOPLEX PERIPHERAL NEEDLE BSP 001185-74 1356-10 14048223017040

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R