BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCA EPIDURAL INTRODUCER

    MDR report key: 110606 · Received July 31, 1997

    Report

    Report Number
    1316297-1997-00004
    Event Type
    Other
    Date Received
    July 31, 1997
    Date of Event
    July 15, 1997
    Report Date
    July 29, 1997
    Manufacturer
    CUSTOM MEDICAL CONCEPTS
    Product Code
    BSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING CAUDAL PROCEDURE, THE DOCTOR PLACED AN SCA EPIDURAL INTRODUCER. WHEN HE ATTEMPTED TO REMOVE THE DEVICE IT BEGAN TO STRETCH AND IT EVENTUALLY BROKE. APPROXIMATELY 1 1/4 INCHES OF THE HYTREL SHEATH REMAINED WITHIN THE PATIENT. THE DOCTOR DECIDED TO LET PIECE REMAIN WITHOUT FURTHER INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCA EPIDURAL INTRODUCER EPIDURAL NEEDLE BSP CUSTOM MEDICAL CONCEPTS NA 020397I

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other RACZ EPIDURAL CATHETER.