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; ¿the data provided is from a chinese article, ¿analysis of complications during central venous catheter placement in neurosurgery.¿ related documents under master complaint case-2020-00007596.The provided translation was presented in excel spreadsheet in english.Per subsequent e-mail it was noted, ¿no additional information is available.¿ without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause of the catheter and/ or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should additional medical information be provided this complaint will be re-assessed.¿ 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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