It was reported that in a clinical observation of "analysis of the effect of different dressings on nursing of central venous catheterization", a patient using a iv3000 suffered a dressing dislodgement.It is unknown if a treatment was performed or if the event was resolved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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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 placement.If the dressing becomes wet or the integrity is compromised, placement may be impacted.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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