BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIDURAL CATHETERIZATION KIT: 19 GA X 35

    MDR report key: 1063468 · Received June 20, 2008

    Report

    Report Number
    1036844-2008-00093
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 30, 2008
    Report Date
    June 20, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    CAZ
    PMA / PMN Number
    K884552
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT EPIDURAL CATHETER "SHEARED OFF". EPIDURAL CATHETER WAS INSERTED IN A FEMALE PATIENT (PT.) AT 0900 BY AN ANESTHESIOLOGIST. PT. DELIVERED BABY AT 1725. PT. ASKED REGISTERED NURSE (RN) TO REMOVE CATHETER 1 HOUR AFTER DELIVERY BECAUSE IT WAS "HURTING HER BACK". AT 1825 PT. SAT UP & RN PULLED GENTLY ON CATHETER & MEET RESISTANCE. RN ASKED PT. TO REPOSITION HERSELF & BEND FORWARD. RN PULLED ON CATHETER & IT CAME OUT IMMEDIATELY, WITHOUT ANY RESISTANCE. RN DID NOT SEE THE TIP OF THE CATHETER & IT WAS FRAYED. ANESTHESIOLOGIST WAS CALLED AT 1830. EXAM REVEALED NO DEFORMITY OF BACK WITH SKIN INTACT. LUMBAR SACRAL CT WAS DONE AT 2202: "SMALL RADIOPAQUE 6.4 CM CATHETER THAT ENTERS THE SPINAL CANAL AT L2 - L3. THE MORE DISTAL PORTION TERMINATES WITHIN THE LEFT PARASPINAL MUSCLE. SURGICAL CONSULTATION IS RECOMMENDED TO RETRIEVE THIS CATHETER." IN 2008, PT. WENT TO OPERATING ROOM FOR REMOVAL OF RETAINED EPIDURAL CATHETER UNDER GENERAL ANESTHESIA. PT. DISCHARGED IN STABLE CONDITION TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIDURAL CATHETERIZATION KIT: 19 GA X 35 ANESTHESIA PRODUCTS CAZ ARROW INTL., INC. RF8056971

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention