BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIDURAL CATHETER, 20G

    MDR report key: 2171276 · Received July 14, 2011

    Report

    Report Number
    MW5021383
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 14, 2011
    Manufacturer
    SMITH MEDICAL NORTH AMERICA
    Product Code
    BSO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE END OF THE EPIDURAL CATHETER BROKE OFF WHEN REMOVING. A (B)(6) FEMALE HAD A PLANNED SURGERY FOR SPINAL FUSION FOR IDIOPATHIC SCOLIOSIS ON (B)(6) 2011. DURING THIS SURGERY AN EPIDURAL CATHETER WAS PLACED FOR POST-OPERATIVE PAIN MANAGEMENT. ON (B)(6) 2011, POST-OP DAY #4, THE CATHETER WAS TO BE REMOVED. AS THEY ATTEMPTED TO REMOVE THE CATHETER, A SEGMENT BROKE OFF AND WAS RETAINED UNDERNEATH THE SKIN. SEVERAL ATTEMPTS WERE MADE BY INTERVENTION RADIOLOGY TO RETRIEVE, BUT UNSUCCESSFUL. ON (B)(6) 2011 - RETURNED TO SURGERY FOR REMOVAL OF RETAINED EPIDURAL CATHETER SEGMENT. THE PIECE WAS IN THE SUBCUTANEOUS TISSUES. THE PIECE WAS REMOVED EASILY. IT WAS ABOUT 13 CM IN LENGTH. NO COMPLICATIONS NOTED FROM THIS 2ND SURGERY AND THE PT WAS DISCHARGED HOME. INFO REGARDING PRODUCT WAS THROWN AWAY AT THE TIME OF THE INITIAL SURGERY SO SPECIFIC PRODUCT DATA IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIDURAL CATHETER, 20G EPIDURAL CATHETER BSO SMITH MEDICAL NORTH AMERICA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Disability