BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOFIX®

    MDR report key: 15542605 · Received October 5, 2022

    Report

    Report Number
    9610825-2022-00397
    Event Type
    Injury
    Date Received
    October 5, 2022
    Date of Event
    September 6, 2022
    Report Date
    August 3, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FMG
    PMA / PMN Number
    K760383
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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). THE COMPLAINT IS UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). WE RECEIVED TWO USED DISCOFIX-3 BLAU 2VER MS WITHOUT PACKAGING. THE RECEIVED SAMPLES WERE TAKEN TO A VISUAL INSPECTION ACCORDING TO TEST METHOD DAMAGES. WE DETECTED THAT THE LA-CONE OF THE USED DISCOFIX-3 BLAU 2VER MS IS BROKEN OFF AND ATTACHED TO A COMPONENT FROM A COMPETITOR. PLEASE NOTE: DIFFICULTIES WHILE SEPARATE THE LOCK-CONNECTION MIGHT OCCUR, IF THE COMPONENTS WERE PRE-MOISTENED WITH INFUSION SOLUTION FOLLOWED BY A HIGH TIGHTENING TORQUE. THEREFORE WE ASSUME OF A PROBLEM DURING THE APPLICATION PROCESS, A HIGH LATERAL FORCE HAS ACTED ON THE CONNECTION. BASED ON THE CONDUCTED INVESTIGATION THE RECEIVED SAMPLES ARE WITHIN THE SPECIFICATION. THEREFORE THE COMPLAINT IS CONSIDERED 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 FRANCE: "STOPCOCK-DAMAGED-BROKEN." ACCORDING TO THE CUSTOMER: "DURING MONITORING BY NURSE. PATIENT FOUND WITH SIGNIFICANT BLEEDING. THE IDE IDENTIFIES THE CAUSE, THE VALVE CONNECTED TO THE CENTRAL VENOUS LINE IS BROKEN AT THE LEVEL OF THE CONNECTOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2675867 DISCOFIX® STOPCOCK FMG B. BRAUN MELSUNGEN AG N/A 21F29D9045

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death