BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION SET

    MDR report key: 1063684 · Received June 20, 2008

    Report

    Report Number
    1036844-2008-00103
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 29, 2008
    Report Date
    June 20, 2008
    Manufacturer
    ARROW INT'L., INC.
    Product Code
    CAZ
    PMA / PMN Number
    K884552
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    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 THAT AFTER THE CATHETER WAS INSERTED, THE CLINICIAN TRIED TO ASPIRATE THE INSIDE OF THE CATHETER WITH THE SYRINGE TO CONFIRM THE CATHETER WAS IN THE EPIDURAL SPACE. AT THAT TIME, HE FELT THE PLUNGER OF THE SYRINGE WAS PULLING WITH MORE EASE THAN USUAL BUT DESPITE THAT, INFUSED THE MEDICAL SOLUTION INTO THE CATHETER. A LEAK WAS THEN DISCOVERED APPROXIMATELY 45 CM FROM THE CATHETER TIP. AS A RESULT, THE CATHETER WAS EXCHANGED WITHOUT DIFFICULTY OR COMPLICATIONS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIDURAL CATHETERIZATION SET ANESTHESIA PRODUCTS CAZ ARROW INT'L., INC. ZF7116124

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK