Product complaint # (b)(4).Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Cerenovus manufacturer's report numbers: 1226348-2020-00038, 1226348-2020-00039, 1226348-2020-00040, 1226348-2020-00041 are related to the same incident.
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Sample was received for evaluation: dhr - product code 82-3113 with lot crcc07; sn (b)(6), conformed to the specifications when released to stock on the 31st march 2014.Gtin (b)(4).Failure analysis - the valve was visually inspected; the stator was dislodged as well as a bump marks in the valve casing were noted.The valve could not be program or pressure tested due to the dislodged stator.The valve was dismantled and was examined under microscope at appropriate magnification: bump marks were noted in the valve casing; corrosion was also noted on the stator.The cam magnets passed per internal process.The root cause for the dislodged stator and bump mark in the valve casing is due to the valve receiving a hard knock.The root cause of the corrosion could not be clearly determined.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)(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.
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