BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCOFIX®

    MDR report key: 16950567 · Received May 17, 2023

    Report

    Report Number
    9610825-2023-00213
    Event Type
    Malfunction
    Date Received
    May 17, 2023
    Report Date
    May 17, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FMG
    PMA / PMN Number
    K760383
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). WE RECEIVED 158 DISCOFIX-3 BLAU 2VER MS IN ORIGINAL PACKAGE. 50 AT THE RECEIVED SAMPLES WERE TAKEN TO A VISUAL INSPECTION FOR DAMAGES ACCORDING TO THE TEST METHOD DAMAGES. DAMAGES OR OTHER DEVIATIONS WERE NOT DETECTED AT THE RECEIVED SAMPLES. IN ADDITION, THE SAME 50 SAMPLES WERE TAKEN TO A FUNCTIONAL TEST IN CONNECTION WITH SEVERAL BBM PRODUCTS. IT WAS POSSIBLE WITHOUT PROBLEMS TO CONNECT AND DISCONNECT THE SEVERAL BBM PRODUCTS WITH THE SAMPLES. FUNCTION FAULTS OR AN EASILY LOOSENING OF THE CONNECTIONS WERE NOT DETECTED. MOREOVER, THE LLA-CONE AND LLI-CONE OF THE SAMPLES WERE TESTED. LLA-CONE WITH A TAPER GAUGE ACCORDING TO DIN EN 20594-1 FIG. 3B (PM: 38340). LLI-CONE WITH A TAPER GAUGE ACCORDING TO DIN EN 20594-1 FIG. 3C (PM: 38251). THE TESTED CONES OF THE SAMPLES ARE WITHIN THE SPECIFICATION. WE DETECTED NO DAMAGES, NO FUNCTIONAL FAULTS AND NO EASILY LOOSENING OF THE CONNECTIONS AT THE RECEIVED SAMPLES. BASED ON THE CONDUCTED INVESTIGATIONS THE 50 TESTED SAMPLES ARE WITHIN THE SPECIFICATION. THEREFORE, WE CONSIDER THE COMPLAINT AS NOT CONFIRMED. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY / TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN GERMANY: "LUER LOCK CONNECTIONS LOOSE.". ACCORDING TO THE CUSTOMER: "LUER LOCK CONNECTIONS COME LOOSE OR CANNOT BE SECURELY CONNECT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705271 DISCOFIX® STOPCOCK FMG B. BRAUN MELSUNGEN AG 23A24D9047

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death