(b)(4), has visited and met the health professionals involved in this case and the following is what they have reported: the main complaint is that the drain is too soft; they say that due to this when the drain bends, it kinks and become occluded which has led to a patient having an haematoma and consequently further surgical treatment.Similar complaint is reported with incident report (b)(4) (redax ref.(b)(4)).The first analysis has been conducted on the production documents of the involved 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.Complaint data base has been reviewed, as well as trend analysis to evaluate similar cases in the last 2 years: trend on specific issue on the product code 24703.No complaints recorded.Trend on all issues on specific lot no.F1801101.No complaints recorded.Trend on product family with similar issue.Complaint from (b)(4).Since the sample was not available for analysis, we have taken from our stock some units coming from other lots in order to performs technical verification.Redax drains have been validated and are in compliance with european standard en 13868 "catheters - test methods for kinking of single lumen catheters and medical tubing" and with en 1618 appendix e relative to the drain flow.However we have repeated the tests in order to evaluate kink resistance and the length of the tubing loop in the kinking and the flow value of smart drain ch 15.The results of the tests indicate that is difficult to perform kinking test according to the standard: it is more difficult when the drain size is more little.However the kink length is < 2 cm for all the sample tested.The length of kinking doesn't change between redax and competitors' drains being equal size; while the flow is upper in redax' drains instead competitors ones.This comparison with competitors has been done only with drain ch 10.No actions will be performed.The tube is in compliance with the international standards and no further complaints have been registered on this product family relative to this specific issue.We have registered the same issue only in the same hospital.
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