Model Number 21-7231 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
Foreign Body In Patient (2687)
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Event Type
malfunction
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Manufacturer Narrative
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Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.
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Event Description
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Distributor reported on behalf of the home care user that the device was in use for infusion.When device was removed from use by patient, the patient noted that the cannula length was about 1mm in length (expected cannula length was 9mm) which meant cannula may have broken and remained in patient skin.The patient reported redness at the infusion site following removal but no other adverse effects were reported.
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Manufacturer Narrative
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One used site was returned for evaluation.Visual inspection observed the soft cannula to be separated from the site approximately 1mm from where it extends out from the base.The remaining piece of cannula was not returned for evaluation.Further inspection was performed using 5x to 40x magnification.The distal end of the cannula was observed to be slightly bent over on one side.No visual abnormalities in the wall thickness of the cannula or any other defects on the device were observed.The crown of the site did not show signs of damage.No evidence was found to suggest the event was caused from an intrinsic defect in the product.
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Search Alerts/Recalls
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