Catalog Number 21-7220-24 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 02/22/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.Event date: in a follow-up report the patient reported that they did not recall the exact event date.
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Event Description
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It was reported that during patient use of the cleo® 90 infusion set, the cannula broke off of the infusion set and remained in the patient's leg.According to the report, the patient discussed the issue with their endocrinologist and the endocrinologist "refused to do anything unless the site became infected".During a follow-up conversation on (b)(6) 2017 the patient reported that the cannula remained in their leg and the issue was ongoing.No permanent adverse effects to patient were reported.
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Manufacturer Narrative
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One used infusion set was returned for evaluation.Visual inspection found the soft cannula separated approximately 1-2 mm from the infusion set base.The remaining cannula length was not returned.Magnified inspection found the distal end of the cannula slightly bent on one side.No other defects were observed.Based on the evidence, the root cause of the issue was unable to be determined.There was no evidence that suggested the issue was caused by an intrinsic defect in the device.
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Search Alerts/Recalls
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