BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIFIX® CONTINUOUS EPIDURAL TRAY

    MDR report key: 6046877 · Received October 21, 2016

    Report

    Report Number
    2523676-2016-00661
    Event Type
    Injury
    Date Received
    October 21, 2016
    Date of Event
    August 30, 2016
    Report Date
    September 26, 2016
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    CAZ
    PMA / PMN Number
    K813186
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE, A THOROUGH SAMPLE ANALYSIS COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. WHILE NO SPECIFIC CONCLUSION CAN BE DRAWN, INCIDENTS OF THIS NATURE CAN OCCUR WHEN A CATHETER BECOMES LODGED BETWEEN RIGID BODY STRUCTURES AND IS STRETCHED BEYOND ITS DESIGN CAPABILITIES; OR IF THE CATHETER IS WITHDRAWN OR PARTIALLY WITHDRAWN THROUGH THE NEEDLE, THEREBY SHEARING THE CATHETER. PER THE INSTRUCTIONS FOR USE (IFU) FOR THE REPORTED PRODUCT CATALOG NUMBER, "DO NOT WITHDRAW CATHETER THROUGH NEEDLE BECAUSE OF THE POSSIBLE DANGER OF SHEARING." REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER OR CATHETER MATERIAL NUMBER. THERE WERE NO OTHER REPORTS OF THIS NATURE AGAINST THE REPORTED LOT NUMBER. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE OR IF THE PHYSICAL SAMPLE IS RECEIVED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED THROUGH MEDWATCH # MW5064578: "EPIDURAL CATHETER TIP SHEARED WHILE IN THE PT'S VESSEL. AFTER SEVERAL HOURS, THE CATHETER WAS ABLE TO BE REMOVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698227 PERIFIX® CONTINUOUS EPIDURAL TRAY PERIFIX FX EPIDURAL CATHETER CAZ B. BRAUN MEDICAL INC. CE17TKFCS 0061493737

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention