BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WILEY - SPINAL

    MDR report key: 1062298 · Received June 18, 2008

    Report

    Report Number
    1316297-2008-00002
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 9, 2008
    Report Date
    June 6, 2008
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Product Code
    BSP
    PMA / PMN Number
    K043467
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS A CUSTOM DEVICE MADE FOR 1 PHYSICIAN. SIXTEEN OF THE 20 PIECES SENT TO THE PHYSICIAN WERE USED WITHOUT INCIDENT. THE 3 PIECES THAT REMAINED IN HIS POSSESSION WERE RETURNED TO EPIMED AT THE TIME THE PHYSICIAN REPORTED THE EVENT. INVESTIGATION REVEALED THAT THE DEVICE WAS DAMAGED DURING MANUFACTURING AND NOT DETECTED DURING FINAL INSPECTION BY QUALITY CONTROL. MEASURES ARE BEING TAKEN TO CORRECT BOTH THOSE ISSUES IN ORDER TO PREVENT THE PROBLEM FROM HAPPENING AGAIN.

    Description of Event or Problem · 1

    DURING PLACEMENT OF A FLEXIBLE SPINAL NEEDLE, THE CANNULA OF THE DEVICE THE DR WAS USING BROKE AT THE SURFACE OF THE SKIN AND PROCEEDED TO RETRACT INSIDE THE BODY APPROX 2CM. AN INCISION WAS MADE AND THE BROKEN PORTION OF THE DEVICE WAS REMOVED FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WILEY - SPINAL ANESTHESIA CONDUCTION NEEDLE BSP EPIMED INTERNATIONAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention