BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CUSTOM KIT

    MDR report key: 5107902 · Received September 28, 2015

    Report

    Report Number
    2183502-2015-00709
    Event Type
    Malfunction
    Date Received
    September 28, 2015
    Date of Event
    September 6, 2015
    Report Date
    September 28, 2015
    Manufacturer
    SMITHS MEDICAL
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SMITHS MEDICAL HAS RECEIVED THE SAMPLE DEVICE. A FULL EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN AS THE DEVICE IS CURRENTLY IN TRANSIT TO THE INVESTIGATION SITE. SMITHS MEDICAL WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING FACILITY PERFORMED A DEVICE HISTORY REVIEW OF THE LOT NUMBER REPORTED (2931382): THE REVIEW SHOWED NO DEVIATIONS OR ABNORMALITIES RELATED TO THE REPORTED ISSUE. ONE USED CATHETER WAS RETURNED TO SMITHS MEDICAL AND ROUTED TO THE MANUFACTURING FACILITY. THE RETURNED DEVICE WAS EXAMINED: THIS EXAMINATION SHOWED THE CATHETER TIP WAS BROKEN OFF; THIS BREAK IN THE MATERIAL WAS DETERMINED CONSISTENT WITH THE DEVICE HAVING BEEN EXPOSED TO A SHARP EDGE. NO SIGNS OF PULL STRESS WERE IDENTIFIED ON THE RETURNED SAMPLE. THE MANUFACTURING FACILITY PERFORMED AN INVESTIGATION OF THE MANUFACTURING PROCESSES FOR PRODUCTION OF THE CATHETER COMPONENT; THIS INVESTIGATION SHOWED NO PRACTICES THAT COULD INDUCE THE CONDITIONS OBSERVED ON THE RETURNED CATHETER. THE MANUFACTURING PROCESS INCLUDES A 100% INSPECTION OF THE CATHETER COMPONENT AND HAD ANY DAMAGE BEEN PRESENT AT THAT TIME THE CATHETER WOULD HAVE BEEN REJECTED. THE ROOT CAUSE COULD NOT BE DEFINITELY ESTABLISHED BUT COULD NOT BE ATTRIBUTED TO MANUFACTURING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON REMOVAL OF THE EPIDURAL CATHETER AFTER 8 HOURS IN USE, THERE WAS BLOOD ON ASPIRATION. RESISTANCE WAS FELT UPON PULLING BACK ON CATHETER AND IT SNAPPED. MRI AND CT SCAN DONE TO CHECK LUMBAR SPACE WHICH DID NOT REVEAL THAT ANY CATHETER FRAGMENTS REMAINED IN THE PATIENT. NO PERMANENT INJURY RESULTED FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639125 EPIDURAL CUSTOM KIT ANESTHESIA CONDUCTION KIT CAZ SMITHS MEDICAL NA 2931382

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR