BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL VENTRICULAR DRAIN

    MDR report key: 10279317 · Received July 15, 2020

    Report

    Report Number
    1226348-2020-00125
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Report Date
    February 20, 2020
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D1, D2, D3, D4, FACILITY REGISTRATION NUMBER INITIAL MDR WAS SENT UNDER FACILITY REGISTRATION NUMBER (B)(4) (MFG. REPORT NUMBER: 1226348-2020-00125). THIS FOLLOW UP #1 MDR IS BEING SUBMITTED TO REPORT THAT THE CORRECT FACILITY ESTABLISHMENT SHOULD BE INTEGRA NEUROSCIENCES PR WITH FACILITY REGISTRATION NUMBER (B)(4). ALSO, PRODUCT ID SHOULD BE XXX-EVD (PREVIOUSLY SUBMITTED AS XXX-HAKIM PROGRAMMABLE VALVE). 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 (B)(4) 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) OFFICE OF PRODUCT EVALUATION AND QUALITY ON JULY 8-9, 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

    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 THAT THE PATIENT HAD VENTRICULOPLEURAL SHUNT THAT HAD BEEN EXTERNALIZED AND ATTACHED TO A STERILE DRAINAGE SYSTEM. PATIENT WAS RECEIVING ANTIBIOTICS. ZOSYN WAS ACCIDENTALLY CONNECTED TO SIDE PORT OF EXTERNALIZED VENTRICULAR SHUNT SYSTEM AND WAS ALLOWED TO INFUSE INTO THE SYSTEM FOR APPROXIMATELY ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740134 EXTERNAL VENTRICULAR DRAIN N/A JXG INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1