It was reported that, before use a iv3000 7x9cm ctn 100, it was confirmed there was a black foreign substance on the dressing.As this was noticed upon inspection, there was not patient involvement.
|
H3, h6: the device, was not used in treatment, has been returned and evaluated, establishing a relationship between the device and the reported event.Visual inspection confirmed there was a black tape on the film.Black tape is used to highlight defective parts of the film material, which should then be removed.After this process there are checks in place in which operators should inspect dressings for black tape.A failed in-process inspection has been identified as the root cause.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 risk files mitigate the reported issue with no updates required.Operators were made aware of this complaint and re-trained the in-process inspection work instruction.Smith and nephew will continue to monitor for any adverse trends relating to this product range.
|