BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 3001271 · Received February 28, 2013

    Report

    Report Number
    9610825-2013-00038
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 30, 2013
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B. BRAUN MEDICAL INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4). NUMEROUS ATTEMPTS TO THE FACILITY TO GAIN ADDITIONAL INFORMATION ON THE EVENT AND THE LOT NUMBER HAVE NOT BEEN SUCCESSFUL AT THIS TIME. ONE SAMPLE WAS RETURNED FOR EVALUATION. THE SAMPLE AND ALL AVAILABLE INFORMATION WERE FORWARDED TO THE ACTUAL MFR, B. BRAUN MALAYSIA, FOR EVALUATION. THEIR INVESTIGATION IS ON GOING AT THIS TIME. A FOLLOW UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REF # (B)(4), LOT # UNKNOWN, 1 ITEM, OCCURRED (B)(6) 2013. REPORTS CLIP DID NOT DEPLOY. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86352 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MELSUNGEN AG NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R