Catalog Number CS-27702-E |
Device Problem
Insufficient Information (3190)
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Patient Problems
Fever (1858); Swelling (2091); Skin Inflammation (2443)
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Event Date 07/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Qn#: (b)(4).Patient condition reported as fine.Additional information states no allergic reaction.
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Event Description
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It was reported that on (b)(6) 2020, repeated fever, local redness and swelling around the catheter, body temperature up to 38.2, considering the possibility of catheter-related adverse reactions.The central venous catheter was removed on (b)(6) 2020, and the patient had normal body temperature, no adverse fluctuations.
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Event Description
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It was reported that on 30 jun 2020, repeated fever, local redness and swelling around the catheter, body temperature up to 38.2, considering the possibility of catheter-related adverse reactions.The central venous catheter was removed on 02 july 2020, and the patient had normal body temperature, no adverse fluctuations.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.The instructions-for-use provided with this kit warns the user, "sterile, single use: do not reuse, reprocess or re-sterilize.Reuse of device creates a potential risk of serious injury and/or infection which may lead to death." without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Search Alerts/Recalls
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