The first analysis have been conducted on the production documents of the subject matter lot: no deviations have been observed on the production and on the labeling and qc records.The lot is made of (b)(4) units; no stock is available, all the units have been distributed on the market starting from year 2016.Complaint data base has been reviewed, as well as trend analysis to evaluate similar cases: trend on specific issue on the product code 24211: we have recorded 2 issues on the same code number during years 2017-2018.The defects are not relevant with the one here indicated.Trend on all issue on specific lot no.F1602131: no complaints.Trend on product family with similar issue: no complaints.No stock of the lot involved is available, so it was not possible to perform further tests on similar products to verify the problem and analyze root causes.When we received the unit, we were not able to perform tests because the drain was cut and just a segment have been received (see picture in annex a).The sample couldn't provide further details.The information collected from the complaint description are not sufficient to understand the dynamics of the incident.The sample couldn't be useful for analysis because just a segment was received and can't be subjected to an examination.The design of the drain has been studied to avoid kinking problems.Considering that no complaints have been received and no particular notes have been found on dhr, we can guarantee that the process produced compliant units.At least could be a defective unit, statistically acceptable inside the lot.In conclusion, we can consider the event an isolated case or probably connected to an incorrect use (use of a not suitable diameter considering the type of surgery performed) or connected with the type of surgery/conditions of the patient.No corrective actions have been considered necessary for the moment.However, we are open to collect and share more information with the hospital and re-evaluate the conclusions of this report in case they want to further examine the event.
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