BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 1013838 · Received March 14, 2008

    Report

    Report Number
    1036844-2008-00042
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 14, 2008
    Report Date
    March 14, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    CAZ
    PMA / PMN Number
    K884552
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    REPORT WAS RECEIVED BY MEDWATCH. IT WAS REPORTED THAT THE CATHETER WAS BEING USED ON A FEMALE PATIENT FOR LABOR & DELIVERY. PATIENT RECEIVED EPIDURAL ANESTHESIA FOR VAGINAL DELIVERY. EXPERIENCED REGISTERED NURSE WAS REMOVING CATHETER WITHOUT RESISTANCE AND NOTED A PORTION OF THE DISTAL CATHETER WAS RETAINED IN THE EPIDURAL SPACE. NEUROSURGERY CONSULT CALLED, CT CONFIRMED RETAINED PORTION IN L2-L3. PATIENT WAS ASYMPTOMATIC AND OPTED FOR CONSERVATIVE TREATMENT AT THIS TIME; MAY REQUIRE SURGICAL REMOVAL IF BECOMES SYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIDURAL CATHETERIZATION KIT ANESTHESIA PRODUCTS CAZ ARROW INTL., INC. RF7113867

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR