BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBE CEV6795B DIA 5MM 350MM

    MDR report key: 9310221 · Received November 12, 2019

    Report

    Report Number
    2523190-2019-00135
    Event Type
    Injury
    Date Received
    November 12, 2019
    Report Date
    October 22, 2019
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ADDITIONAL INFORMATION ON 12NOV2019 AND 28NOV2019 THAT STATED THERE WAS SPUTTERING AND SMOKE, BUT NO FLAME. THE USER HAD A SUPERFICIAL BURN INJURY DURING THE UROLOGY PROCEDURE AND IT IS UNKNOWN HOW THE INJURY WAS TREATED. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND A SURGICAL DELAY (UNSPECIFIED TIME) WAS REPORTED TO CHANGE THE DEVICE. THE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR LOT NO. 121001 REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WERE OBSERVED. THE EVALUATION WAS UNABLE TO CONCLUSIVELY VERIFY THE COMPLAINT AS VALID, THEREFORE AN INVESTIGATION FOR CAUSE WAS UNABLE TO BE PERFORMED. THE DEVICE IS COMPLAINT WITH THE SPECIFICATIONS. IT DID NOT HIGHLIGHT ANY DEFECT. 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)(6), DIRECTOR OF REGULATORY PROGRAMS, OFFICE OF PRODUCT EVALUATION AND QUALITY AND (B)(6), 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 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. LINKED TO MFG REPORT NUMBERS:2523190-2019-00134 AND 2523190-2019-00136.

    Description of Event or Problem · 1

    2 OF 3 REPORTS. A CUSTOMER REPORTED THAT A CEV6795B TUBE DIA 5MM 350MM WAS NOT WORKING, SPUTTERING AND SMOKING. THERE WAS PATIENT CONTACT HOWEVER, IT IS UNKNOWN IF THERE WAS ANY PATIENT INJURY/DEATH. AN UNSPECIFIC INCREASE IN SURGICAL TIME WAS REPORTED. REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107571 TUBE CEV6795B DIA 5MM 350MM PFM16 GEI INTEGRA MICROFRANCE S.A.S. 121001 SAV 11-15

    Patients

    Seq Age Sex Outcome Treatment
    1 CEV634-1A, INSERT| CEV669B, HANDLE