BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN LUMBER CATHETER KIT

    MDR report key: 10275448 · Received July 15, 2020

    Report

    Report Number
    1226348-2020-00135
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Report Date
    February 26, 2020
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K964923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UDI - (B)(4). COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPORTED A LUMBAR DRAIN CATHETER (ID 821707 - CODMAN LUMBER CATHETER KIT) BECAME DISCONNECTED: THE LUMBAR DRAIN WAS INSERTED ON AN INTUBATED / VENTILATED PATIENT. ONE-HOUR POST INSERTION CRITICAL CARE NURSING STAFF NOTED THERE HAD BEEN NO FLUID DRAINAGE FOR THE HOUR AND WHEN CHECKING THE DRAIN LINE OBSERVED THAT THE BED WAS WET. ON CLOSER INSPECTION THE LUMBAR DRAIN HAD BEEN INADVERTENTLY DISCONNECTED. FOLLOWING DISCUSSION BETWEEN THE PHYSICIANS AND NURSING STAFF, IT APPEARS THAT THE DISCONNECTION OCCURRED WHERE THE CATHETER CONNECTS TO THE LUER SPIGOT (DESPITE THE SUTURE USED TO REINFORCE THE CONNECTION). THERE WAS NO HARM TO THE PATIENT AND ALL APPROPRIATE ACTIONS / PRECAUTIONS WERE TAKEN AT THE TIME (LUMBAR DRAIN TUBING WRAPPED IN STERILE GAUZE AND CLAMPED WITH ARTERY FORCEPS). PATIENT'S NEUROLOGICAL CONDITION WAS UNCHANGED. OBSERVATIONS SHOWED NO SPIKES IN TEMPERATURE. FOLLOWING FURTHER DISCUSSIONS WITH THE NEURO NURSING TEAM, IT APPEARS THAT THE METHOD OF FIXING THE FLEXIBLE D TUBE OVER THE LUER LOCK CONNECTOR SPIGOT CAN LEAD TO INADVERTENT DISCONNECTION AND INADVERTENT LOSS OF CSF FLUID / INFECTION RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744840 CODMAN LUMBER CATHETER KIT SHUNT, NERVOUS SYSTEM & COMPS JXG INTEGRA LIFESCIENCES MANSFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1