BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIAL EVD 10-110 W/O Y SITE

    MDR report key: 10278388 · Received July 15, 2020

    Report

    Report Number
    2648988-2020-00008
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    April 1, 2019
    Report Date
    February 26, 2020
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K920156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE IDENTIFIER: (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) OF FG LOT 3242604 WAS REVIEWED AND NO ANOMALY WAS REPORTED DURING THE MANUFACTURING, PACKAGING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED TO THE REPORTED CONDITION. THE FAILURE ANALYSIS AND ROOT CAUSE CANNOT BE COMPLETED BECAUSE THE PRODUCT WAS NOT RETURNED. THE REPORTED CONDITION CANNOT BE CONFIRMED. 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 DONNA ENGLEMAN, DIRECTOR OF REGULATORY PROGRAMS, OFFICE OF PRODUCT EVALUATION AND QUALITY AND MICHELLE RIOS, ASSISTANT DIRECTOR, MDR TEAM, OFFICE OF PRODUCT EVALUATION AND QUALITY ON JULY 8-9, 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT YET RECEIVED BY THE MANUFACTURER FOR EVALUATION. 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 MEDWATCH FORM WITH UF/ IMPORTER REPORT # (B)(4) WAS RECEIVED ON 11FEB2020 WITH THE FOLLOWING INFORMATION: A NURSE WAS NOTIFIED BY THE PATIENT¿S ATTENDANT THAT THE SP0090 SPECIAL EVD 10-110 W/O Y SITE WAS BROKEN. THE ATTENDANT STATED THAT THE PATIENT¿S PILLOW FELL OFF THE BED AND UNSURE IF THIS CAUSED THE TRANSDUCER TO SNAP OFF, OR WHETHER IT WAS A DEFECTIVE EQUIPMENT. IT IS UNKNOWN IF THERE WAS ANY INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740531 SPECIAL EVD 10-110 W/O Y SITE N/A JXG INTEGRA NEUROSCIENCES PR 3242604

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR