BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX®

    MDR report key: 8769250 · Received July 8, 2019

    Report

    Report Number
    9610825-2019-00244
    Event Type
    Malfunction
    Date Received
    July 8, 2019
    Date of Event
    June 6, 2019
    Report Date
    July 8, 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 · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) INTERNAL REPORT # (B)(4) - EVENT 1. AS WE RECEIVED NO SAMPLE, AN EXAMINATION WAS NOT POSSIBLE. A REVIEW OF THE BATCH AND MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED, AS NO BATCH NUMBER HAS BEEN PROVIDED. THE PRODUCT DESIGN IS BEING UPDATED TO INCREASE THE FORCE REQUIRED TO OPEN THE CATHETER CONNECTOR UNDER CHANGE CONTROL: (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.

    Description of Event or Problem · 1

    EVENT 1: AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4)): CLIP DETACHED. THERE IS A SERIES OF COMPLAINTS THAT THE ALLIGATOR CLIP COMES OFF AFTER EPIDURAL SURGERY. THREE CASES HAVE BEEN REPORTED SINCE MAY. NO SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561054 PERIFIX® EPIDURAL ANESTHESIA KIT OGE B. BRAUN MELSUNGEN AG N/A

    Patients

    Seq Age Sex Outcome Treatment
    1