BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIMITORR VOLUME LIMITING EVD 20 ML

    MDR report key: 1820090 · Received August 24, 2010

    Report

    Report Number
    2648988-2010-00054
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    May 14, 2010
    Report Date
    August 24, 2010
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORTED INFORMATION AND EVALUATION OF RETURNED UNIT, THE REPORTED CONDITION (I.E. LIMITORR WOULD NOT DRAIN) WAS CONFIRMED. THE UNIT WAS THOROUGHLY EXAMINED AND INSPECTED. AN OCCLUSION WAS FOUND FROM THE BURETTE TO THE DRAIN BAG CAUSED BY SOLVENT USED IN THE TUBING JOINT JUST BELOW THE BURETTE. THE DEVICE HISTORY RECORD (DHR) OF LOT # 1101634 WAS REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS OF THE PRODUCT. AN OCCLUSION TEST IS PERFORMED AS PART OF THE MANUFACTURING PROCESS. THE INVESTIGATION IS DOING REFERENCE THAT ONE OF THE POTENTIAL CAUSES OF THIS OCCLUSION COULD BE ASSIGNED TO EXCESSIVE ADHESIVE APPLIED AND/OR THE PRODUCT DID NOT PASS THROUGH THE OCCLUSION TEST DUE TO AN OVERSIGHT OF MANUFACTURING PERSONNEL. CAPA (B)(4) WAS INITIATED IN ORDER TO CAPTURE A THOROUGH INVESTIGATION OF THE ROOT CAUSE OF THIS TYPE OF INCIDENT AND DOCUMENT ALL CORRECTIVE AND PREVENTIVE ACTIONS TO AVOID AND/OR ELIMINATE THE RECURRENCE OF THIS CONDITION. AN AWARENESS TRAINING WAS PROVIDED TO MANUFACTURING PERSONNEL IN ORDER TO EMPHASIZE THE IMPORTANCE OF OCCLUSION TEST TO PREVENT INCIDENT LIKE THIS AND FOLLOW THE MANUFACTURING PROCEDURES AS ESTABLISHED TO APPLY THE ADHESIVE IN THIS AREA.

    Description of Event or Problem · 1

    A LIMITORR VOLUME LIMITING EVD 20ML WOULD NOT DRAIN. THE EVENT WAS DESCRIBED AS: A FEMALE PATIENT IN HER SIXTIES WAS BEING WORKED UP FOR NORMAL PRESSURE HYDROCEPHALUS. A LIMITORR VOLUME LIMITING EVD 20ML WOULD NOT DRAIN. THE EVD WAS REPLACED AND WORKED FINE. NO INJURY OCCURRED AS A RESULT OF THIS EVENT. IT IS UNKNOWN WHETHER THE UNIT WAS FLUSHED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIMITORR VOLUME LIMITING EVD 20 ML NA JXG INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1