BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY® 3

    MDR report key: 8154854 · Received December 12, 2018

    Report

    Report Number
    9610825-2018-00258
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Report Date
    January 21, 2019
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    UDI-DI
    04046964014079
    PMA / PMN Number
    K111236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 B. BRAUN INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4) ONE (1) USED SAMPLE WAS RECEIVED FOR EVALUATION. UNDER VISUAL EXAMINATION IT WAS DETERMINED THAT THE FULL CATHETER WAS PRESENT, THE CATHETER TIP HAD NOT BEEN SHEARED/TORN OFF. HOWEVER, THE CATHETER TIP DID EXHIBIT DAMAGE. THIS PRODUCT IS SUBJECTED TO A 100% INSPECTION BY AN IN-LINE VISION SYSTEM THAT IS CALIBRATED AND SUBJECTED TO REGULAR VERIFICATIONS TO ENSURE IT IS FUNCTIONING PROPERLY. THE DEFECT OBSERVED IN THE RETURNED SAMPLE WOULD HAVE BEEN DETECTED AND REJECTED BY THE IN-LINE VISION SYSTEM. REVIEW OF THE DEVICE HISTORY RECORD PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER OR LOT NUMBER. BASED ON THE RESULTS OF THE INVESTIGATION, NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 B. BRAUN INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. ADDITIONAL ATTEMPTS TO GET THE SAMPLE ARE BEING MADE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY USER FACILITY: WHEN THE CATHETER WAS REMOVED FROM THE PATIENT'S RIGHT FOREARM, IT APPEARED TO BE MISSING THE LAST 1MM. STAFF BELIEVE THE LAST 1MM OF CATHETER BROKE OFF INTO THE PATIENT'S FOREARM. PATIENT WAS X-RAYED, AND NOTHING WAS SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996913 INTROCAN SAFETY® 3 CATHETER,INTRAVASCULAR,THE FOZ B. BRAUN MELSUNGEN AG 4251131-02 UNKNOWN 04046964014079

    Patients

    Seq Age Sex Outcome Treatment
    1