BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX®

    MDR report key: 8712442 · Received June 19, 2019

    Report

    Report Number
    9610825-2019-00224
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Date of Event
    May 15, 2019
    Report Date
    July 2, 2019
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    OGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). IT SHOULD BE NOTED THAT BECAUSE THE INITIAL REPORT WAS SUBMITTED UNDER EXEMPTION NUMBER E2016018, THIS FOLLOW-UP REPORT WILL ALSO BE REPORTED UNDER THE EXEMPTION NUMBER. THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT THE BRANDING AND PRODUCT CODE SECTIONS D1 AND D2, AS WELL AS TO UPDATE THE RESULT AND METHOD CODES IN SECTION H6 TO REFLECT THE DESIGN CHANGE REFERENCED BELOW. THE PRODUCT DESIGN IS BEING UPDATED TO INCREASE THE FORCE REQUIRED TO OPEN THE CATHETER CONNECTOR UNDER CHANGE CONTROL: HC-CHC-M-DIV-1306. 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.

    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 B. BRAUN MELSUNGEN AG INTERNAL REPORT #(B)(4). WE RECEIVED NO SAMPLE AND NO PICTURE. THE DEFECT IS DUE TO A DEVELOPMENT ERROR AND ALREADY KNOWN. THEREFORE THIS COMPLAINT IS CONSIDERED CONFIRMED. A REVIEW OF THE BATCH AND MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED, AS NO BATCH NUMBER HAS BEEN PROVIDED. THE COMPLAINT IS FILED FOR STATISTICAL PURPOSE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN FRANCE: CONNECTOR/CATHETER-DETACHED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504437 PERIFIX® EPIDURAL ANESTHESIA KIT OGE B. BRAUN MELSUNGEN AG N/A

    Patients

    Seq Age Sex Outcome Treatment
    1