BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPOCAN COMBINED SPINAL/EPIDURAL TRAYS

    MDR report key: 4170271 · Received September 26, 2014

    Report

    Report Number
    2523676-2014-00346
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 28, 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
    NY, 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 CATHETER AND ONE UNUSED CATHETER WERE RECEIVED FOR EVAL. THE UNUSED CATHETER APPEARED INTACT AND NO ANOMALIES OR FRACTURED ENDS WERE VISUALLY OBSERVED. THE USED CATHETER WAS MISSING THE BLUE TIP AND APPEARED FRACTURED AT THE TIP END. UNDER MICROSCOPIC OBSERVATION, THE FRACTURED END APPEARED STRETCHED AND FRAYED. THIS TYPE OF DAMAGE IS CONSISTENT WITH EPIDURAL CATHETERS IN WHICH A SECTION IS PULLED BEYOND ITS DESIGN CAPABILITIES. THIS CAN OCCUR WHEN A CATHETER BECOMES LODGED BETWEEN RIGID BODY STRUCTURES. 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 INFO HAS BEEN FORWARDED TO THE DEVICE MANUFACTURER OF THE CATHETER. 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 WHEN THE CATHETER WAS REMOVED THE TIP BROKE OFF IN THE PT. REPORTER IS UNAWARE IF THERE WERE ANY PROBLEMS WITH THE INSERTION OR REMOVAL. THE CATHETER DID NOT LOOK STRETCHED. THE TIP WAS NOT SURGICALLY REMOVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599767 ESPOCAN COMBINED SPINAL/EPIDURAL TRAYS PERIFIX 20 GA. EPIDURAL CATHETER CAZ B. BRAUN MEDICAL, INC. ES1827KDS 0061354255

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other