BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX®

    MDR report key: 8789221 · Received July 15, 2019

    Report

    Report Number
    9610825-2019-00260
    Event Type
    Malfunction
    Date Received
    July 15, 2019
    Date of Event
    June 19, 2019
    Report Date
    July 15, 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

    EVENT 1: (B)(4). VISUAL INSPECTION: RECEIVED A FILTER CONNECTED TO CONNECTOR; THE CONNECTOR LID WAS CLOSED. CONNECTOR VISUAL INSPECTION: NO ABNORMALITIES OBSERVED. FUNCTIONAL TEST: CATHETER TENSILE STRENGTH TEST: CONNECTOR SAMPLE AND UNUSED CATHETER WAS USED FOR THIS TEST; COMPANY SPECIFICATIONS: ABOVE 11N; TEST RESULTS: 14.4N; THE SAMPLE MET COMPANY SPECIFICATIONS. OTHERS: CONNECTION CHECK: WE WERE ABLE TO CONNECT AN UNUSED CATHETER TO THE CONNECTOR WITHOUT RESISTANCE AND UP TO THE MARKING POINT. NO ABNORMALITIES OBSERVED. 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): CATHETER DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584319 PERIFIX® EPIDURAL ANESTHESIA KIT OGE B. BRAUN MELSUNGEN AG N/A

    Patients

    Seq Age Sex Outcome Treatment
    1