It was reported that, during set up for treatment, it was confirmed there was a foreign substance in the pad of a melolin sterile 20x10cm ctn 100.It was found in 2 dressings in the carton.Treatment was performed, with a back-up device instead.Patient was not injured as consequence of this problem.
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H3, h6: the device was returned for evaluation, confirming the reported event.Visual examination of the returned product confirmed the presence of the back marks, with the root cause established as a quality related issue.A documentation review has been conducted, confirming previous complaints of this nature, relating to a manufacturing quality problem, no historical escalations have been observed.A review of the device history confirmed that the product was released according to specification.A process review was conducted, with corrective action implemented to reduce the probability of further reoccurrences.The instructions for use contain comprehensive instructions on the safe operation and use of the device.The risk files mitigate the reported issue with no updates required.This investigation is now complete with no additional actions deemed necessary at this stage.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.H5.
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