BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY® 3

    MDR report key: 8967251 · Received September 5, 2019

    Report

    Report Number
    9610825-2019-00388
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Report Date
    September 5, 2019
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    PMA / PMN Number
    K111236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 A SAMPLE, AN ITEM NUMBER OR A BATCH NUMBER, FURTHER INVESTIGATION IS NOT POSSIBLE. A THOROUGH SAMPLE ANALYSIS COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: CATHETER BROKE OFF WHILE ACCESSING VEIN. THE CATHETER WAS STICKING OUT OF THE PATIENT, AND WAS ABLE TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758878 INTROCAN SAFETY® 3 CATHETER,INTRAVASCULAR,THE FOZ B. BRAUN MELSUNGEN AG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1