BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIMED RACZ CATHETER

    MDR report key: 2211483 · Received August 9, 2011

    Report

    Report Number
    MW5021703
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    July 15, 2011
    Report Date
    August 9, 2011
    Manufacturer
    EPIMED
    Product Code
    BSO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A CAUDAL EPIDURAL STEROID INJECTION WITH A RACZ CATHETER. AT THE CONCLUSION OF THE PROCEDURE, WHILE WITHDRAWING THE CATHETER, A FRAGMENT OF THE SHEATH MEASURING LESS THAN HALF THE LENGTH OF THE SHEATH SHEARED OFF AND WAS RETAINED IN THE CAUDAL CANAL. THE RETAINED FRAGMENT WAS NOT VISIBLE AT THE SKIN AND NOT PALPABLE SUBCUTANEOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIMED RACZ CATHETER RACZ CATHETER BSO EPIMED 135-1735 12354307

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR