BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROR EPIDURAL CATHETERIZATION KIT

    MDR report key: 3972836 · Received April 28, 2014

    Report

    Report Number
    1036844-2014-00168
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 28, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER, HOWEVER, A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON LOT NUMBER 23F13G0444, BASED ON SALES HISTORY AND THERE WERE NO RELEVANT FINDINGS. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORDS FOR THE EPIDURAL NEEDLE WERE REVIEWED WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 1

    COMPLAINT ALLEGES THAT THE TIP OF THE NEEDLE WAS BENT DURING USE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253488 ARROR EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION CATHETER CAZ ARROW INTL., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1