This medical device report is filed retrospectively following fda observation number 4 received by degania medical devices pvt.Ltd.During the fda inspection of 4-7 of november 2019.The observation was related to the fact that degania medical devices pvt.Ltd.Did not establish procedures for reporting mdrs to fda as a manufacturer.Till then all complaints related to the devices produced by dmd were assessed for mdr reportability and submitted as necessary to fda by degania silicone ltd.Another q medical devices division closely affiliated with dmd.Dmd capa number (b)(4) was issued to address the observation.One of the capa actions requires dmd to perform retrospective review of all the complaints received during 2018 and 2019 and submit to fda retrospective mdrs for the reportable events (with reference to original reported to fda in the borders of recall activity; report # (b)(4).Incorrect temperature reading was caused by defective sensors, which are purchased component.Degania silicone purchased and assembled the sensors into its silicone catheter.It was explained by the supplier of sensors, that the cracks in defective thermistor tip did not appear immediately but developed following impact of different factors like time, transportation conditions, humidity.This is the reason the inprocess degania tests did not detect the problem.Corrective and preventive action has already been taken at supplier end.Improved control of grinding quality by line leaders and qc staff.Improved visual aids are put on working station.Aql acceptance criteria of incoming sensors will be changed by degania.
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This is retrospective submission, following re-assessment of our customer complaints during period 2018-2019.Customer's text, "according to the reporter, the device gave a different temperature measurement of 35.2 degrees compared with a general-purpose sensor of 36.4 degrees in the rectum." there was no patient injury.
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