BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 3271699 · Received July 25, 2013

    Report

    Report Number
    9610825-2013-00088
    Event Type
    Malfunction
    Date Received
    July 25, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K982805
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER (B)(4). B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER), AND B. BRAUN MEDICAL INC (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT #(B)(4). NO SAMPLES WERE RECEIVED FOR EVALUATION. ALL AVAILABLE INFORMATION REGARDING THIS EVENT WAS FORWARDED TO THE INTROCAN MANUFACTURER, B. BRAUN (B)(4). THEIR INVESTIGATIONAL REPORT STATES THAT A REVIEW OF MANUFACTURING RECORDS WAS NOT POSSIBLE BECAUSE NO LOT NUMBER WAS AVAILABLE. THEIR REPORT ALSO INDICATES THAT A COMPLETE INVESTIGATION COULD NOT BE CONDUCTED WITHOUT A SAMPLE TO EVALUATE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AND NO SPECIFIC CONCLUSION CAN BE DRAWN. A HISTORICAL REVIEW OF THE CUSTOMER COMPLAINT DATABASE REVEALED NO ADVERSE TRENDS OF THIS NATURE AGAINST THE REPORTED CATALOG NUMBER. IF ADDITIONAL PERTINENT INFORMATION COMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IMP - (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347325 INTROCAN SAFETY I.V. SAFETY CATHETER FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1