Catalog Number 21-7231-24 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Type
malfunction
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Manufacturer Narrative
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Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
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Event Description
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It was reported that the cannula of a cleo® 90 infusion set broke off in the patient's abdomen.No permanent injury was reported.See mfr: 3012307300-2017-00990, 3012307300-2017-00991, and 3012307300-2017-00992.
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Manufacturer Narrative
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Additional information was received from the initial reporter which stated that this file is a duplicate of mfr# 2183502-2016-00041.As this file is a duplicate it is no longer considered a complaint and is therefore not a reportable event.(b)(4).
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Search Alerts/Recalls
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