It was reported that, during the set up for npwt, when a large npwt foam filler kit was opened, the pouch was not crimped and was not kept sterilized.Treatment was performed, without any delay, 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, the root cause remains unknown.A visual inspection confirmed that the seal was not intact.Although the seal was confirmed to be incomplete, there is clear evidence of adhesive transfer in the seal area, which confirms that this product was fully sealed during the manufacturing process.The probable root cause may include the seal may have been inadvertently opened when taken out of the packaging case, or that it failed during the transportation and storage stage.A documentation review has been conducted, confirming that no manufacturing problems or sterility issues have been observed.No previous complaints of this nature are recorded, historical observations detail that this issue is fully captured within the preliminary risk assessment.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 manufacturing problems observed no corrective actions deemed necessary.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.
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