BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANESTHESIA EPIDURAL CUSTOM TRAY

    MDR report key: 3705396 · Received March 14, 2014

    Report

    Report Number
    2523676-2014-00051
    Event Type
    Injury
    Date Received
    March 14, 2014
    Report Date
    February 24, 2014
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    CAZ
    PMA / PMN Number
    K840179
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    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 EVALUATION. WITHOUT THE ACTUAL SAMPLE OR LOT NUMBER, A THOROUGH EVALUATION 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. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER OR CATHETER MATERIAL NUMBER. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE DEVICE MANUFACTURER OF THE CATHETER. 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: REPORTS THAT 5 CM OF THE CATHETER SHEARED OFF IN THE PATIENT. CUSTOMER INDICATED THAT THE FRAGMENT WAS NOT VISUALIZED ON THE CT SCAN. THE PATIENT WAS POSTPARTUM WITH OTHER COMPLICATIONS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154868 ANESTHESIA EPIDURAL CUSTOM TRAY EPIDURAL CATHETER CAZ B. BRAUN MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other