It was reported that, during wound treatment, there were many black spots in the film after opening the package.It was found in six (6) boxes of opsite flexigrid 6x7cm ctn 100.Treatment was resumed, without any delay, with a smith and nephew back-up device.Patient is fine and was not harmed.No further complications reported.
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H3, h6; it was reported that, during wound treatment, there were many black spots in the film after opening the package.It was found in six (6) boxes of opsite flexigrid 6x7cm ctn 100.Treatment was resumed, without any delay, with a smith and nephew back-up device.Patient is fine and was not harmed.No further complications reported.The device was returned for analysis and was submitted to surface analysis for examination.Microscopic analysis revealed that the black coloured staining was believed to be crystallised cleaning product, of an unspecified nature.We have therefore been able to confirm a relationship between the event and the device, however, cannot identify a definitive root cause.A lot number was provided and the batch records were reviewed.It was confirmed that the product(s) had progressed through a satisfactory release process which involved testing the product against the requirements of the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.(despite repeated attempts, smartsolve would not save the separate dhr task) a complaint history review (chr) revealed a very small number of similar instances in the last 12 months.A risk management review was conducted and which mitigated the reported issue with no further action or updates required.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.A review concluded that there are no prior escalated actions related to this product and the reported event.The probable root cause for this complaint is that the markings on the device(s) have been placed there during the manufacturing process.The machines involved are cleaned at regular intervals, and it is believed that liquid cleaning product has been left on a component part of the machine, which has then been transferred to the device(s).This liquid has then crystallised as a result of the remaining manufacturing processes which take place, resulting in the markings as described.Investigations into this complaint are now complete and no further actions by smith & nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith & nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
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