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Catalog Number UNKN05003901 |
Device Problems
Loss of or Failure to Bond (1068); Difficult to Remove (1528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/10/2014 |
Event Type
malfunction
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Event Description
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On the literature article named "a pilot trial of bordered polyurethane dressings, tissue adhesive and sutureless devices compared with standard polyurethane dressings for securing short-term arterial catheters." the authors of the study reported that, during arterial catheter treatment with iv3000 dressing and veni-grad (conmed).1 patient from the bpu group had adhesive residue during the removal of the dressing.It is unknown if the residue was from the iv3000 dressing or the competitor's dressing.Additional details are unknown.Patient outcome is unknown.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Manufacturer Narrative
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H3, h6: on the literature article named "a pilot trial of bordered polyurethane dressings, tissue adhesive and sutureless devices compared with standard polyurethane dressings for securing short-term arterial catheters.", the authors of the study reported that, during arterial catheter treatment with iv3000 dressing and veni-grad (conmed), 1 patient from the bpu group had adhesive residue during the removal of the dressing.It is unknown if the residue was from the iv3000 dressing or the competitor's dressing.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.As no lot number was provided it was not possible to carry out a device history review a complaint history review revealed a similar instance in the last three years.The risk files, mitigate the reported issues with no updates required.A clinical review concluded that without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.Probable root cause is incorrect skin preparation, incorrect application or removal of dressings or infrequent dressing changes.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 skin preparation prior to use, application and removal of dressings and recommended frequency of dressing changes.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.
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Manufacturer Narrative
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On the literature article named "a pilot trial of bordered polyurethane dressings, tissue adhesive and sutureless devices compared with standard polyurethane dressings for securing short-term arterial catheters.", the authors of the study reported that, during arterial catheter treatment with iv3000 dressing and veni-grad (conmed), 1 patient from the bpu group had adhesive residue during the removal of the dressing.It is unknown if the residue was from the iv3000 dressing or the competitor's dressing.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.As no lot number was provided it was not possible to carry out a device history review a complaint history review revealed a similar instance in the last three years.The risk files, mitigate the reported issues with no updates required.A clinical review concluded that without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.Probable root cause is incorrect skin preparation, incorrect application or removal of dressings or infrequent dressing changes.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 skin preparation prior to use, application and removal of dressings and recommended frequency of dressing changes.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.
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Search Alerts/Recalls
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