It was reported that when the pouch was opened, it was confirmed there was a tiny black foreign substance in the hydrosite ad plus 7.5 x 7.5cm.The treatment was completed, without delay, using a s+n back up device.Patient was not harmed as consequence of this problem.
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The device had been returned and evaluated, establishing a relationship between the device and the reported event.The returned dressing was cut and observed under microscope.The tiny black substance was embedded in pad, and suspected to be fibre of clothing.The root cause has been identified that clothing fiber dropped into foam during casting process, and the dressing escaped from on-line inspection.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file contains further instances of the reported events.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 corrective actions required.Operators were made aware of this complaint, and trained with gmp requirement and on-line inspection requirement.Smith and nephew will continue to monitor for any adverse trends relating to this product range.
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