BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESPOCAN

    MDR report key: 2171906 · Received March 1, 2007

    Report

    Report Number
    2523676-2007-00003
    Event Type
    Other
    Date Received
    March 1, 2007
    Date of Event
    January 31, 2007
    Report Date
    February 7, 2007
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    BSP
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS RETURNED TO THE MFR TO BE EVALUATED. THE ESPOCAN NEEDLE WAS OBSERVED TO BE SEPARATED FROM THE NEEDLE HUB. A 20MM PORTION OF THE BLUNT END OF THE NEEDLE WAS BENT AT A 10 DEGREE ANGLE. IT COULD NOT BE DETERMINED IF THE NEEDLE WAS BENT AND DAMAGED DURING REMOVAL FROM THE PT OR IF THE CANNULA ENCOUNTERED SOME TYPE OF TRAUMA, BEFORE IT SEPARATED FROM THE HUB. MICROSCOPIC EVAL REVEALED NO PORTION OF THE CANNULA INSIDE THE HUB. THE DETACHED CANNULA ALSO APPEARED INTACT. NO SPECIFIC CONCLUSIONS CAN BE DRAWN AT THIS TIME. ALTHOUGH NO INVENTORY REMAINED OF THE REPORTED LOT, THE HOUSE RETAINS FOR THE REPORTED LOT WERE SUBJECTED TO A PULL TEST OF THE NEEDLE TO THE HUB USING A TENSILE FORCE TESTER. ALL SAMPLES EXCEEDED THE MINIMUM JOINT SEPARATION DESIGN SPECIFICATION AND PASSED THE JOINT INTEGRITY TEST. THE SAMPLE AND ALL AVAILABLE INFO HAS BEEN PROVIDED TO THE ACTUAL MFR, (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: CRNA WAS INSERTING NEEDLE FOR ADMIN OF EPIDURAL. OUTWARD TRACTION WAS APPLIED TO WINGS OF HUB. THE NEEDLE SEPARATED FROM THE HUB AND WENT UNDER THE SKIN WITH SEPARATION. REQUIRED SURGICAL PROCEDURE TO REMOVE. NEEDLE WAS REMOVED INTACT. ADD'L INFO PROVIDED BY THE FACILITY INDICATED THE NEEDLE WAS SURGICALLY REMOVED WITHOUT INCIDENT AND THE PT SUFFERED NO ADD'L ADVERSE SEQUELA ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPOCAN COMBINED SPINAL AND EPIDURAL SET BSP B. BRAUN MEDICAL, INC. ES1725 60865708

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other| R