It was reported that the paper of three (3) dressings of a box of infusion set adhesive tape 6x7cm are not releasing the adhesive patch.The device was used for treatment and was not returned for analysis.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.The batch records were reviewed and it could be confirmed that the products 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.A complaint history review revealed no similar instances in the last three years.A risk management review concluded that without further information the alleged failure mode and any associated harm can not be directly linked to a specific failure mode within the risk file although it contains several failure modes that can result in increased adherence to other materials.No update to the risk file is required.Probable root cause is that the device has been stored in the incorrect conditions and not in accordance with the ifu.The devices must be stored in the conditions outlined to prevent environmental factors such as temperature from affecting them.An increase in temperature above that recommended may affect the adhesive nature of the device, which can cause issues such as those described in the event.The users of the reported product are advised to consult the ifu, to prevent future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including the correct conditions in which the device must be stored.This investigation is now complete, with no corrective actions required.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
|