BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY®

    MDR report key: 8383329 · Received March 1, 2019

    Report

    Report Number
    9610825-2019-00030
    Event Type
    Malfunction
    Date Received
    March 1, 2019
    Date of Event
    January 11, 2019
    Report Date
    March 1, 2019
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    DYB
    UDI-DI
    04046963318161
    PMA / PMN Number
    K021094
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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). . THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE A THOROUGH SAMPLE ANALYSIS COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THE USER FACILITY DID PROVIDE A POTENTIAL BATCH, 18A25G8273, FOR THE DEVICE, HOWEVER THIS BATCH WAS MANUFACTURED AFTER THE DATE OF THE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD PERFORMED FOR THE REPORTED BATCH 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. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 0

    AS REPORTED ON MEDWATCH MW5083288: PREMATURE BABY AT (B)(6) WEEKS GESTATION WAS RECEIVING IV FLUIDS, THE CATHETER WAS PLACED ON (B)(6) 2019 AT 2210, WAS LEAKING ON (B) (6) 2019. WHEN IT WAS EVALUATED TO BE REMOVED. THE CATHETER DID NOT COME OUT. THE PART UNDER THE SKIN BROKE AND WAS REMOVED INTACT. NO PART OF THE CATHETER WAS RETAINED. ADDITIONAL INFORMATION RECEIVED FROM THE USER FACILITY: THE RETAINED PIECE OF CATHETER WAS REMOVED AT THE BEDSIDE, AND NO ADDITIONAL TREATMENT OR SURGERY WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174705 INTROCAN SAFETY® INTRODUCER, CATHETER DYB B. BRAUN MELSUNGEN AG 4252511-02 UNKNOWN 04046963318161

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA Required Intervention