BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX®

    MDR report key: 8830552 · Received July 26, 2019

    Report

    Report Number
    9610825-2019-00305
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    June 27, 2019
    Report Date
    July 26, 2019
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    OGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS EVENT 1 OF B. BRAUN (B)(4) INTERNAL REPORT # (B)(4). NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. IF THE SAMPLE AND/OR ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    EVENT 1: AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN THE (B)(4)): CATHETER SLIPS OUT OF PERIFIX CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624867 PERIFIX® EPIDURAL ANESTHESIA KIT OGE B. BRAUN MELSUNGEN AG N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1