BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN® SAFETY

    MDR report key: 5050376 · Received September 2, 2015

    Report

    Report Number
    9610825-2015-00372
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    July 30, 2015
    Report Date
    August 12, 2015
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    DQR
    PMA / PMN Number
    K982805
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE RECEIVED ONE USED INTROCAN SAFETY PUR 22G, 0.9X25MM-SA WIHTOUT PACKAGING. THE SAMPLE WAS TAKEN TO A VISUAL EXAMINATION. THE CAPILLARY OF THE INTROCAN SAFETY PUR 22G, 0.9X25MM-SA WAS PENETRATED BY THE INTROCAN CANNULA APPROXIMATELY 10 MM FROM THE TIP. THE AREA OF THE PUNCTURE SHOWS A V-SHAPED DAMAGE. THE OBSERVED FAILURE MODE IS CONSISTENT WITH TESTS WHICH HAVE BEEN CONDUCTED WHEREBY THE CANNULA PIERCES THE CAPILLARY TUBING DUE TO WITHDRAWING AND PUSHING FORWARD AGAIN..." ACCORDING TO THIS DAMAGE THIS EVENT IS MOST LIKELY AN APPLICATION PROBLEM AND CONSIDER THE COMPLAINT NOT JUSTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY SHIPPING FROM (B)(6) TO BBM IN (B)(4) FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE. THE REPORTED MATERIAL NO.(B)(4) AND BATCH NO. 15C23G8316 COMBINATION DOES NOT EXIST IN OUR SAP SYSTEM. FOR (B)(4), THE CORRECT MATERIAL NUMBER IS (B)(4) AND UPON REVIEW OF DHR AGAINST COMPLAINT BATCH NO. 15C23G8316, THERE IS NO SUCH DEFECT ENCOUNTERED DURING IN-PROCESS INSPECTION AND AT FINAL CONTROL INSPECTION.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4) ): "AT THE TIME OF PUNCTURE OCCURRED VEIN TRANSFIXATION WITH POLYURETHANE CATHETER BREAKAGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581609 INTROCAN® SAFETY I.V. SAFETY CATHETER DQR B. BRAUN MELSUNGEN AG N/A 15C23G8316

    Patients

    Seq Age Sex Outcome Treatment
    1