BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIFIX CONTINUOUS EPIDURAL TRAY

    MDR report key: 4208720 · Received October 24, 2014

    Report

    Report Number
    2523676-2014-00382
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    July 10, 2014
    Report Date
    September 26, 2014
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    CAZ
    PMA / PMN Number
    K813186
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    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 EVALUATION COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THE EVENT DESCRIPTION DID INDICATE THAT THE CATHETER APPEARED STRETCHED WHEN COMPARED TO AN UNUSED CATHETER. 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 IT'S DESIGN CAPABILITIES. 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. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE DEVICE MANUFACTURER OF THE CATHETER. IF A PHYSICAL SAMPLE IS RECEIVED OR IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY THROUGH MEDWATCH (B)(4): REPORT REPEAT C-SECTION WITH USE OF EPIDURAL ANESTHESIA. UPON DISCONTINUATION OF THE EPIDURAL CATHETER, IT WAS NOTED THAT THE BLUE TIP WAS NOT PRESENT ON THE END OF THE EPIDURAL CATHETER. IT APPEARS TO HAVE STRETCHED WHEN LINED UP NEXT TO A NON-USED CATHETER OF THE SAME TYPE. A FOLLOW-UP CT DID NOT REVEAL PRESENCE OF THE CATHETER. THE NEUROSURGEON DID NOT FEEL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679758 PERIFIX CONTINUOUS EPIDURAL TRAY PERIFIX 20 GA. EPIDURAL CATHETER CAZ B. BRAUN MEDICAL INC. CE18TKCDLS 0061364311

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other