H3,h6: we have now concluded our investigation for the complaint received.A review of the batch manufacturing records could not be performed as no part or lot numbers were provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.A complaint history review was carried out across all iv3000 products, there have been further complaints reported with this failure mode in the past three years.The devices were intended for use in treatment.As no samples were returned a product evaluation could not be carried out.Dressings should be periodically monitored to ensure proper catheter placement.If the dressing becomes wet or the integrity is compromised, catheter placement may be impacted.A clinical evaluation was carried out.It was concluded; ¿information obtained from a literature review publication, "clinical observation of needle-free closed joint for central venous catheter infusion in neurosurgery" indicates a patient was using iv3000 for fixation and had problems due to infusion set slippage.There is no information regarding to the outcome of the patient or the treatment provided for this complication.There is no identifying patient information or supporting relevant clinical documentation provided.Therefore, a clinical assessment is unable to be performed at this time.¿ we have not been able to confirm a relationship between the event and the device or identify a definitive root cause.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.
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