BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIMITORR VOLUME LIMITING EVD 20 ML

    MDR report key: 10288698 · Received July 17, 2020

    Report

    Report Number
    2648988-2019-00102
    Event Type
    Injury
    Date Received
    July 17, 2020
    Date of Event
    October 16, 2019
    Report Date
    October 24, 2019
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K072929
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UDI NUMBER: (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. A PHOTO WAS PROVIDED BY THE CUSTOMER SHOWING A FEMALE LUER CONNECTOR. NO DEFECT WAS OBSERVED ON THE CONNECTOR SHOWN IN THE PHOTO. THE DEVICE HISTORY RECORD (DHR) REVIEW OF THE REPORTED LOT DID NOT SHOW ANY ANOMALY DURING THE MANUFACTURING AND PACKAGING PROCESSES OF THE DEVICE THAT COULD BE RELATED TO THE REPORTED CONDITION. ALSO, NO ANOMALY WAS REPORTED TO THE FEMALE LUER CONNECTOR USED. THE COMPLAINT COULD NOT BE CONFIRMED. IT IS UNKNOWN IF THE CATHETER USED WAS AN INTEGRA CATHETER. AS PER IFU INFORMATION, ¿THE LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE SYSTEM IS COMPATIBLE WITH ALL INTEGRA EXTERNAL CSF DRAINAGE LUMBAR OR VENTRICULAR CATHETERS. A CATHETER TUBING ADAPTER AND LUER CONNECTOR ARE PROVIDED WITH THE DRAINAGE SYSTEM.¿ IFU ALSO STATES THAT ¿INTEGRA MAKES NO CLAIM FOR OR REPRESENTATION AS TO THE PERFORMANCE CHARACTERISTICS OF THIS PRODUCT IF IT IS USED IN CONJUNCTION WITH COMPONENTS OF OTHER MANUFACTURERS.¿ THESE LUER CONNECTORS ARE BARBED TO AVOID CATHETER SLIPPING AND LIGATURES MAY BE USED TO PROVIDE ADDITIONAL HOLD. CATHETERS¿ IFU ADVISES TO TAKE CARE NOT TO CUT OR TEAR THE TUBING WHEN PLACING THE LIGATURES. PROBABLE ROOT CAUSE FORE THIS EVENT COULD BE THAT THE CATHETER WAS INADVERTENTLY PULLED CAUSING THE DISCONNECTION; NONETHELESS, AS PREVIOUSLY MENTIONED, LIGATURES MAY BE USED TO FURTHER SECURE THE CATHETER TO THE LUER CONNECTOR. BETWEEN 05NOV2019 AND 30JUN2020, APPROXIMATELY 2,200 MDRS SUBMITTED ELECTRONICALLY BY INTEGRA LIFESCIENCES VIA TRACKWISE, INTEGRA'S COMPLAINT HANDLING SYSTEM, WERE NOT RECEIVED BY CDRH DUE TO A COMPUTER SYSTEM ISSUE. WITHIN THIS TIME PERIOD, AN ERROR WITH INTEGRA'S MIDDLEWARE, WHICH FACILITATES COMMUNICATIONS BETWEEN TRACKWISE AND THE FDA SYSTEM, CAUSED THE COMPLAINT RECORDS TO CLOSE AND INDICATE WE HAD RECEIVED AN ACKNOWLEDGEMENT 3 FROM THE FDA WHEN WE HAD NOT. INTEGRA INTERPRETED THE ACKNOWLEDGEMENT AS A SUCCESSFUL SUBMISSION; HOWEVER, SUBSEQUENT INVESTIGATION REVEALED THE ACKNOWLEDGEMENT 3 RECEIVED WAS FROM OUR MIDDLEWARE AND NOT FROM THE FDA (THESE ACKNOWLEDGEMENTS HAVE BEEN RETAINED AS PART OF THE DOCUMENTATION OF THE MDR). THE MALFUNCTION WAS RELATED TO THE RELOCATION OF THE TRACKWISE APPLICATION TO A NEW DATA CENTER DURING THE TRANSITION OF INTEGRA'S CORPORATE HEADQUARTERS FROM PLAINSBORO, NJ TO PRINCETON, NJ. PREVIOUSLY, INTEGRA HAD BEEN SUCCESSFULLY RECEIVING ACKNOWLEDGEMENTS 1, 2, AND 3 FROM THE FDA, AND OUR RECORDS REFLECT THESE ACKNOWLEDGEMENTS, INCLUDING THE DATE AND TIME STAMPS. CAPA PR 229048 AND NC 20-011 HAVE BEEN OPENED BY INTEGRA TO FURTHER INVESTIGATE THE NONCONFORMANCE AND DEVELOP A CORRECTIVE ACTION PLAN. THE MIDDLEWARE ERROR HAS BEEN CORRECTED, AND INTEGRA HAS FILED MDRS SINCE THE CORRECTION AND VERIFIED THAT THE APPROPRIATE ACKNOWLEDGEMENTS HAVE BEEN RECEIVED FROM THE FDA. INTEGRA IS RESUBMITTING ALL IMPACTED MDR REPORTS FOR THE TIME PERIOD 05NOV2019 THROUGH 30JUN2020. INTEGRA LIFESCIENCES CONTACTED (B)(4), DIRECTOR OF REGULATORY PROGRAMS, OFFICE OF PRODUCT EVALUATION AND QUALITY AND (B)(4), ASSISTANT DIRECTOR, MDR TEAM, OFFICE OF PRODUCT EVALUATION AND QUALITY ON JULY 8-9, 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT EXPECTED TO BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A CLINICAL PROJECT MANAGER REPORTED THAT ON (B)(6) 2019, THE INS9020 LIMITORR VOLUME LIMITING EVD 20 ML WAS DISCONNECTED AND CEREBROSPINAL FLUID (CSF) LEAKAGE WAS NOTED IN PATIENT'S BED. THE ADAPTER HAD SLIPPED OFF THE DRAIN CATHETER SIDE. THERE WAS NO KNOWN TIME WHEN THE CATHETER WAS DISCONNECTED. THERE WAS NO LOCKING MECHANISM NOTED ON THE ADAPTER TO ENSURE IT WOULD NOT COME APART. PATIENT WAS REPORTED TO EXPERIENCE HEADACHE AND PAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754769 LIMITORR VOLUME LIMITING EVD 20 ML N/A JXG INTEGRA NEUROSCIENCES PR 3484443

    Patients

    Seq Age Sex Outcome Treatment
    1