BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW EPIDURAL CATHETERIZATION KIT

    MDR report key: 3994022 · Received July 24, 2014

    Report

    Report Number
    1036844-2014-00289
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED BY THE CUSTOMER FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE KIT AND THE LIDOCAINE WITH EPINEPHRINE AMPULE AND THERE WERE NO RELEVANT FINDINGS. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THE POTENTIAL ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INFO PROVIDED AND WITHOUT A SAMPLE. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED BECAUSE NO SAMPLE WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORDS FOR THE KIT AND THE LIDOCAINE WITH EPINEPHRINE AMPULE WERE REVIEWED WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THE POTENTIAL CAUSE OF A CRACKED MEDICATION AMPULE COULD NOT BE DETERMINED BASED UPON THE INFO PROVIDED AND WITHOUT A SAMPLE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE 1.5% LIDOCAINE W/EPI. VIAL CRACKED DURING USE. NO PT OR USER INJURY/HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434756 ARROW EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION KIT CAZ ARROW INTL., INC. 23F14C1010

    Patients

    Seq Age Sex Outcome Treatment
    1