BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERICAN EPIDURAL CANNULA

    MDR report key: 3632371 · Received February 7, 2014

    Report

    Report Number
    2523676-2014-00016
    Event Type
    Injury
    Date Received
    February 7, 2014
    Date of Event
    January 14, 2014
    Report Date
    January 14, 2014
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    BSP
    PMA / PMN Number
    K813179
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC.(B)(4). ONE USED EPIDURAL NEEDLE, WITHOUT THE ORIGINAL PACKAGING, WAS RECEIVED FOR EVALUATION. THE NEEDLE WAS BROKEN IN HALF WITH SEVERAL BENDS OBSERVED ALONG THE CANNULA, INCLUDING A BEND AT THE POINT OF FRACTURE. INCIDENTS OF THIS NATURE CAN GENERALLY OCCUR WHEN THE NEEDLE IS SUBJECTED TO SOME TYPE OF TRAUMA DURING USE THAT STRESSES THE DEVICE BEYOND ITS DESIGN CAPABILITIES. THE DAMAGE OBSERVED ON THE RETURNED NEEDLE APPEARS CONSISTENT WITH THE DEVICE BEING SUBJECTED TO AN EXCESSIVE FORCE WHICH BENT AND ULTIMATELY FRACTURED THE NEEDLE. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER OR NEEDLE MATERIAL NUMBER. THERE ARE NO OTHER REPORTS OF THIS NATURE AGAINST THE REPORTED LOT NUMBER. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE NOTED DURING IN-PROCESS OR FINAL PRODUCT INSPECTION. ALL AVAILABLE INFO HAS BEEN FORWARDED TO THE DEVICE MANUFACTURER OF THE NEEDLE. 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 WHILE PERFORMING AN EPIDURAL, THE NEEDLE BROKE PART WAY UNDER THE SKIN. IT IS UNK IF ANYTHING UNEXPECTED OCCURRED DURING THE PROCEDURE. THE BROKEN NEEDLE WAS RETRIEVED FROM THE PT WITH A SURGICAL INCISION. THE ACTUAL PROCEDURE THE PT HAD COME IN FOR WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81116 PERICAN EPIDURAL CANNULA CONTINUOUS EPIDURAL ANESTHESIA NEEDLE BSP B. BRAUN MEDICAL, INC. NA 0061327934

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention