BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURECAN SAFETY II

    MDR report key: 7522498 · Received May 17, 2018

    Report

    Report Number
    2532083-2018-00005
    Event Type
    Malfunction
    Date Received
    May 17, 2018
    Report Date
    June 11, 2018
    Manufacturer
    B. BRAUN MEDICAL FRANCE
    Product Code
    FPA
    UDI-DI
    04046955156276
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS EVENT TWO OF B. BRAUN INC. INTERNAL REPORT NUMBER (B)(4). ONE USED DEVICE WAS RECEIVED FOR EVALUATION. THE SAFETY MECHANISM WAS TESTED, AND IT COULD BE ACTIVATED WITHOUT ANY DIFFICULTIES. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER. A BATCH RECORD REVIEW FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NON-CONFORMANCES OF THIS NATURE. BASED ON THE RESULTS OF THIS INVESTIGATION, NO SPECIFIC CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT. THE RETURNED DEVICE MET REQUIREMENTS ACCORDING TO SPECIFICATION, AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 0

    AS REPORTED BY USER FACILITY: EVENT 2: WHEN THE TECHNICIAN WAS REMOVING THE HUBER NEEDLE FROM THE PATIENT, THE SAFETY MECHANISM DID NOT ACTIVATE. THE SAFETY MECHANISM SLIDES TO THE BOTTOM OF THE NEEDLE BUT DOESN'T ENGAGE. NO PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS EVENT TWO OF B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY USER FACILITY: EVENT 2: WHEN THE TECHNICIAN WAS REMOVING THE HUBER NEEDLE FROM THE PATIENT, THE SAFETY MECHANISM DID NOT ACTIVATE. THE SAFETY MECHANISM SLIDES TO THE BOTTOM OF THE NEEDLE BUT DOESN'T ENGAGE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363995 SURECAN SAFETY II SET, ADMINISTRATION, INTRA FPA B. BRAUN MEDICAL FRANCE 4447006-02 17L17G8661 04046955156276

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR