BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX®

    MDR report key: 8604006 · Received May 13, 2019

    Report

    Report Number
    9610825-2019-00146
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Date of Event
    April 12, 2019
    Report Date
    May 13, 2019
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    OGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS EVENT ONE OF B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). NO SAMPLE HAS BEEN RETURNED FOR INVESTIGATION. WITHOUT THE ACTUAL SAMPLE A THOROUGH INVESTIGATION CAN NOT BE PERFORMED. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE ACTUAL MANUFACTURER. THE PRODUCT DESIGN IS BEING UPDATED TO INCREASE THE FORCE REQUIRED TO OPEN THE CATHETER CONNECTOR UNDER CHANGE CONTROL: (B)(4). 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN JAPAN): EVENT 1 CATHETER WAS DETACHED FROM CONNECTOR: STAFF CONNECTED A CATHETER WITH A CONNECTOR AND CHECKED THAT THEY WERE FIRMLY CONNECTED. BUT THE CATHETER WAS DETACHED FROM THE CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397249 PERIFIX® EPIDURAL ANESTHESIA KIT OGE B. BRAUN MELSUNGEN AG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1