BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX CONTINUOUS EPIDURAL TRAY

    MDR report key: 4544459 · Received February 12, 2015

    Report

    Report Number
    2523676-2015-00028
    Event Type
    Malfunction
    Date Received
    February 12, 2015
    Date of Event
    December 23, 2014
    Report Date
    January 20, 2015
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    CAZ
    PMA / PMN Number
    K813186
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B BRAUN MEDICAL INC., INTERNAL REPORT #(B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVAL. WITHOUT THE ACTUAL SAMPLE OR LOT NUMBER, A THOROUGH EVAL 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BECOMES LODGED BETWEEN RIGID BODY STRUCTURES AND IS STRETCHED BEYOND ITS DESIGN CAPABILITIES, OR IF THE CATHETER IS WITHDRAWN OR PARTIALLY WITHDRAWN THROUGH THE NEEDLE, THEREBY SHEARING THE CATHETER.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, "CAUTION: DO NOT WITHDRAW CATHETER THROUGH NEEDLE BECAUSE OF THE POSSIBLE DANGER OF SHEARING." 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 A PHYSICAL SAMPLE IS RECEIVED OR IF ADD'L PERTINENT INFO BECOMES AVAILABLE, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS THE EPIDURAL CATHETER TIP EITHER BROKE OFF OR SHEARED IN THE PT. THE CATHETER TIP WAS RETAINED IN THE PT. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103643 PERIFIX CONTINUOUS EPIDURAL TRAY PERIFIX 20 GA. EPIDURAL CATHETER CAZ B. BRAUN MEDICAL, INC. CE18TKCD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK