BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMBAR CATH KIT II W/EDS III

    MDR report key: 3434990 · Received October 29, 2013

    Report

    Report Number
    1226348-2013-31821
    Event Type
    Injury
    Date Received
    October 29, 2013
    Date of Event
    October 22, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK954021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    PLEASE BE ADVISED THAT THIS REPORT IS BEING FILED TO INCLUDE THE CAPA NUMBER FOR THIS COMPLAINT. TRENDS ARE BEING MOITORED WITH CAPA (B)(4).

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE PRODUCT CODE WAS 82-1731 NOT 82-1738 AS PREVIOUSLY REPORTED. THE EDS III WAS VISUALLY INSPECTED AND CONFIRMED THAT THE TUBING HAS COME AWAY FROM THE PATIENT LINE STOP COCK AND NEEDLESS PORT. ONCE THE HOSPITAL TAPE HAD BEEN REMOVED FROM AROUND THE TUBING, GLUE TRACES WERE NOTED ON THE TUBING, STOP COCK AND NEEDLESS PORT. THE CURRENT QUALITY INSPECTION FOR THESE ASSEMBLIES IS ESTABLISHED TO 100% TEST FOR LEAK AND BLOCKAGE. THE FLOW PROBLEM REPORTED COULD BE DUE TO THE FILTER AT THE TOP OF THE DRIP CHAMBER COMING IN CONTACT WITH BIOLOGICAL DEBRIS CAUSING A BLOCKAGE. THIS HOWEVER THIS COULD NOT BE DETERMINED. THE EDS III WAS SET UP IN THE LAB FOR FLOW TEST, THE FLOW WAS NORMAL. REVIEW OF THE HISTORY DEVICE RECORDS WAS NOT POSSIBLE AS THE LOT NUMBER WAS UNKNOWN. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT THERE WAS A DISCONNECTION OF THE PATIENT TUBING LINE IN WHICH A LEAKAGE OCCURRED. IT WAS NOT POSSIBLE TO DRAIN THE CSF FROM THE DRIP CHAMBER TO THE COLLECTION BAG. ALTHOUGH WE HAVE NOT YET RECEIVED CONFIRMATION AS TO THE ACTIONS TAKEN BY THE PHYSICIAN IT MIGHT BE LIKELY THAT THE DEVICE WAS CHANGED AS IT IS MENTIONED IN THE SYNERGY FORM THAT IT WILL BE RETURNED FOR INVESTIGATION. AS A RESULT OF A POSSIBLE CHANGE OF DEVICE WE WOULD CLASSIFY THE COMPLAINT AS A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554574 LUMBAR CATH KIT II W/EDS III SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention