Catalog Number 21-7230-24 |
Device Problem
Migration (4003)
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Patient Problems
Skin Discoloration (2074); Alteration In Body Temperature (2682)
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Event Date 01/20/2019 |
Event Type
malfunction
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Manufacturer Narrative
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According to the report the sample was discarded.
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Event Description
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Information was received that during use of this smiths medical cadd cleo infusion sets, "the plastic end of the cleo set broke off in the patient's arm".It was reported that the site had been in for 4 days.According to the report "the patient developed a temperature and the site became reddened".Reported that surgical consult was ordered to cut out the plastic tip and site had to be sutured.No additional adverse event reported.
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Event Description
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The reporter stated the cannula broke "at the base of cannula" where it attaches to the infusion site.The reporter confirmed no photographs of the product were available.When clinician was asked about potential causes of the reported event, the clinician stated they determined the location of the infusion site (back of patient's arm) would have "frequently rubbed against the bed because patient was quite mobile".The clinician also stated the site was "left in for 4 days" which "may have contributed" to the cannula break.
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Search Alerts/Recalls
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