Catalog Number 383033 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Itching Sensation (1943); Swelling (2091); Reaction (2414)
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Event Date 05/27/2019 |
Event Type
Injury
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd intima-ii¿ closed iv catheter system was used and the patient had an allergic reaction.This was discovered during use.The following information was provided by the initial reporter: it's noticed that redness, swelling and itchiness on the insertion site "o.5h" after start infusion.The insertion site was treated with "iodov," then symptom improved.
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Event Description
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It was reported that bd intima-ii¿ closed iv catheter system was used and the patient had an allergic reaction.This was discovered during use.The following information was provided by the initial reporter: it's noticed that redness, swellness and itchy on the insertion site o.5h after start infusion the insertion site was treated with iodov then symptom then improved.
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Manufacturer Narrative
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Investigation: a sample nor photo was provided for the investigation.At this time a possible root cause can not be determined.Dhr was performed and no abnormalities were observed.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of reaction with lot #8305868 regarding item #383033.
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Search Alerts/Recalls
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