BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCANS SAFETY

    MDR report key: 4201734 · Received October 17, 2014

    Report

    Report Number
    9610825-2014-00378
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 25, 2014
    Report Date
    October 1, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    PMA / PMN Number
    K982805
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE RECEIVED ONE USED CANNULA OF AN INTROCAN SAFETY-W PUR 20G, 1.1X32MM-EU IN OPEN PACKAGING. THE RECEIVED SAMPLE WAS TAKEN TO A VISUAL EXAMINATION. IN AS-RECEIVED CONDITION THE SAFETY CLIP WAS PROPERLY ACTIVATED ON THE TIP OF THE CANNULA. WE DETECTED NO DAMAGES OR OTHER IRREGULARITIES AT THE SURFACE OF THE RAW CANNULA. IN ADDITION THE SAFETY CLIP WAS TAKEN TO A FUNCTIONAL TEST (SLIDING THE SAFETY CLIP ON THE RAW CANNULA). IT WAS EASILY POSSIBLE TO SLIDE THE SAFETY CLIP ON THE RAW CANNULA AND TO FIX THE CLIP ON THE TIP OF THE CANNULA. THE SPECIAL FEATURE OF A SELF-ACTIVATING SAFETY CLIP THAT AUTOMATICALLY COVERS THE NEEDLES SHARP BEVEL WAS GIVEN. WE ASSESS THIS COMPLAINT TO BE NOT JUSTIFIED. WE HAVE INFORMED OUR MANUFACTURER ACCORDINGLY. REVIEWED THE DEVICE HISTORY RECORD AND THERE WERE NO SUCH DEFECT ENCOUNTERED DURING IN-PROCESS AND FINAL CONTROL INSPECTION. PROCESS CARDS SHOW NO ABNORMALITIES. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4)): DURING DISPOSAL OF SHARP, THE OPERATOR IS ACCIDENTALLY STUCK BECAUSE THE SAFETY SYSTEM DIDN'T WORK CORRECTLY. HE WILL HAVE TO SUBMITTED TO THE DIAGNOSTIC PROCEDURES. THE SAFETY SYSTEM STARTED WHEN THE BAG OF THE CONSERVATION OF THE NEEDLE ACCIDENTALLY FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663430 INTROCANS SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MELSUNGEN AG NA 3K0725A318

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK