BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 2980097 · Received February 21, 2013

    Report

    Report Number
    9610825-2013-00025
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    January 23, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    PMA / PMN Number
    K982805
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4) (MANUFACTURER). (B)(4). THE ACTUAL DEVICE INVOLVED WAS NOT RETURNED FOR EVAL HOWEVER, WE RECEIVED A BROWN PARTICLE. THE BROWN PARTICLE WAS SUBJECTED TO A VISUAL EXAM. THE PARTICLE WAS APPROXIMATELY 8 MM LONG. THE PARTICLE WAS FLEXIBLE. ACCORDING TO THE CUSTOMERS STATEMENT THE BROWN PARTICLE WAS DETECTED INSIDE THE VEIN OF THE PT. THEY RECOGNIZED A PART OF PLASTIC INSIDE THE VEIN. WHEN REMOVED, THEY SAW THE PLASTIC WAS ATTACHED TO THE VEIN WALL. WE HAVE INFORMED OUR PRODUCTION SITE ACCORDINGLY. THE INVESTIGATION IS ON GOING AT THIS TIME. A F/U REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFO BY BBM SALES ORGANIZATION IN (B)(6)): WHEN THE NURSE REMOVED THE CATHETER THEY DETECTED SOMETHING INSIDE THE VEIN OF THE PT. THEY RECOGNIZED A PART OF THE PLASTIC INSIDE THE VEIN. WHEN REMOVED THEY SAW THE PLASTIC WAS ATTACHED TO THE VEIN WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75036 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MELSUNGEN AG NA 2G07258232

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R