BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW EPIDURAL CATHETERIZATION KIT

    MDR report key: 3955715 · Received June 12, 2014

    Report

    Report Number
    1036844-2014-00267
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNK, AT THE TIME OF THIS REPORT, IF THE DEVICE SAMPLE IS AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE CATHETER TIP APPEARS TO BE TOO STIFF. CLINICIAN CONCERN FOR INTRA-VASCULAR PLACEMENT OR SUBDURAL PLACEMENT. THE PT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347694 ARROW EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDITION KIT CAZ ARROW INTL., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1