BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY®

    MDR report key: 6140760 · Received December 2, 2016

    Report

    Report Number
    9610825-2016-00834
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    November 13, 2016
    Report Date
    November 17, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    DQR
    UDI-DI
    04046963185206
    PMA / PMN Number
    K021094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. 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 MEDICAL INTERNAL REPORT NUMBER (B)(4). THE DEVICE INVOLVED WAS NOT RETURNED FOR FURTHER EVALUATION; HOWEVER A PHOTO WAS RECEIVED AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. 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 INTERNAL REPORT NUMBER (B)(4). ONE (1) PHOTO OF THE FAILED DEVICE WAS RECEIVED; HOWEVER, BASED ON THE EVALUATION OF THE PHOTO, THE MANUFACTURE WAS UNABLE TO DETERMINE THE CAUSE OF THE INCIDENT. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE SAMPLE. NO SAMPLE WAS RETURNED FOR EVALUATION; BECAUSE OF THIS, FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE AND NO CONCLUSION COULD BE DRAWN FROM THE PHOTO. HENCE, THE COMPLAINT IS ASSESSED TO BE NOT JUDGEABLE. A HISTORICAL REVIEW OF THE COMPLAINT DATABASE IDENTIFIED NO ADVERSE TRENDS FOR PRODUCT CODE 4251652-02 OR LOT NUMBER INVOLVED. IF A SAMPLE AND/OR ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED. DEVICE HISTORY RECORD (DHR): REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO NON CONFORMANCES OR DEVIATIONS WERE NOTED IN PROCESS AND FINAL INSPECTION.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: PROBLEM: AFTER INSERTING IV CATHETER, WHEN CUSTOMER WENT TO REMOVE THE NEEDLE, THE SAFETY DEVICE DID NOT ENGAGE PROPERLY. PHOTO PROVIDED. NO INJURY. NO SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792427 INTROCAN SAFETY® I.V. SAFETY CATHETER DQR B. BRAUN MELSUNGEN AG 16C17G8316 04046963185206

    Patients

    Seq Age Sex Outcome Treatment
    1