BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX®

    MDR report key: 8727801 · Received June 24, 2019

    Report

    Report Number
    9610825-2019-00236
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Date of Event
    May 20, 2019
    Report Date
    June 24, 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 TWO OF B. BRAUN MELSUNGEN AG INTERNAL REPORT(B)(4). RECEIVED 2 PCS OF CONNECTORS. VISUAL INSPECTION. FIRST ONE. A FILTER WAS CONNECTED TO THE CONNECTOR. THE COVER OF THE CONNECTOR WAS OPEN. INSIDE THE CONNECTOR WAS BROKEN FRAGMENTED CATHETER. THE CATHETER WAS 26MM LONG, WITH BOTH ENDS BROKEN. NO ABNORMALITY WAS FOUND ON CONNECTOR. SECOND ONE. A FILTER WAS CONNECTED TO THE CONNECTOR. THE COVER OF THE CONNECTOR WAS OPEN. NO ABNORMALITY WAS FOUND ON CONNECTOR. FUNCTIONAL TEST. TENSILE TEST WAS CONDUCTED WITH RETURNED CONNECTOR AND UNUSED CATHETER. THE RESULT WAS 13.8N AND 14.2N, BOTH SATISFY THE STANDARD OF >11N. UNUSED CATHETER WAS ABLE TO BE SMOOTHLY INSERTED UP TO TARGET POSITION, AND CONNECTOR COVER WAS LOCKED SECURELY. 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 · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN JAPAN): EVENT 2 CATHETER DETACHED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520146 PERIFIX® EPIDURAL ANESTHESIA KIT OGE B. BRAUN MELSUNGEN AG UNNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1