BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM EPIDURAL ANESTHESIA TRAY

    MDR report key: 4257358 · Received November 12, 2014

    Report

    Report Number
    2523676-2014-00409
    Event Type
    Injury
    Date Received
    November 12, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 14, 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
    OH, US
    Reporter Occupation
    PHARMACIST

    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, A THOROUGH EVALUATION COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THE EVENT DESCRIPTION DID INDICATE THAT RESISTANCE WAS FELT WHEN TRYING TO READJUST THE 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 ITS 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 PRODUCT CATALOG NUMBER OR CATHETER MATERIAL NUMBER. THERE WERE NO OTHER REPORTS OF THIS NATURE AGAINST THE REPORTED LOT NUMBER. ALL AVAILABLE INFO HAS BEEN FORWARDED TO THE DEVICE MFR OF THE CATHETER. IF A PHYSICAL SAMPLE IS RECEIVED OR IF ADDITIONAL PERTINENT INFO BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS THE ANESTHESIA PROVIDER HAD AN ISSUE WITH THE EPIDURAL CATHETER, BUT THE ISSUE WAS UNK AT THE TIME. DURING A FOLLOW-UP CALL WITH THE FACILITY, THE DOCTOR REPORTED THAT THE CRNA PLACED THE EPIDURAL CATHETER IN LABORING PT. WHEN TRIED TO READJUST, RESISTANCE WAS FELT AND THE CATHETER DID SNAP LEAVING ABOUT 7CM OF THE CATHETER IN THE PT. THIS WAS CONFIRMED ON A FOLLOW-UP CT SCAN WITH THE NEUROSURGEON. NO INTERVENTION IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729466 CUSTOM EPIDURAL ANESTHESIA TRAY PERIFIX EPIDURAL CATHETER CAZ B. BRAUN MEDICAL, INC. NA 0061376392

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other