It was reported that, during set up for wound treatment, was confirmed a foreign substance adhered on the strip in one dressing of a leukostrip 13x102mm ctn 50.As this was noticed before treatment, there was not any patient involved.
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H3, h6: the product has been returned and evaluated, the event is confirmed.Visual inspection of the dressing has confirmed the reported contamination, this has been confirmed to be additional adhesive, this is not any other form of contamination.A documentation review has revealed previously cases with a similar nature, there are no open corrective actions.The manufacturing records confirm the device met the final product specifications and contain no contributory factors to the reported event, the associated risk files mitigate this event type.A review of the manufacturing process has revealed the probable cause.A probable cause includes the defect was not picked out from raw material prior to production, retraining has been conducted, to reduce the probability of future occurrences.No corrective actions are deemed necessary, at this stage, smith and nephew will continue to monitor for adverse trends relating to the reported event.
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