Catalog Number CA-45703-P1A |
Device Problem
Biocompatibility (2886)
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Patient Problem
Anaphylactic Shock (1703)
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Event Date 07/05/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported the patient experienced an anaphylaxis response to the chlorhexidine in the catheter.The catheter was removed, case was canceled, and patient moved to the icu.The patient had a full recovery within 24 hours.Post removal of catheter, the patient tested positive/sensitive to chg.The patient's current condition was reported as "fine".No information was available regarding the symptoms the patient experienced or the treatment received.
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Event Description
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It was reported the patient experienced an anaphylaxis response to the chlorhexidine in the catheter.The catheter was removed, case was canceled, and patient moved to the icu.The patient had a full recovery within 24 hours.Post removal of catheter, the patient tested positive/sensitive to chg.The patient's current condition was reported as "fine".No information was available regarding the symptoms the patient experienced or the treatment received.
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Manufacturer Narrative
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(b)(4).The device was not returned for investigation.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The report of a catheter related allergic reaction was confirmed based on the customer report.The customer confirmed that the patient had an allergy/sensitivity to chlorhexidine.The labeling provided with the coated catheter states "the arrowg+ard blue antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine and/or sulfa drugs." therefore, based on the reported event and customer confirmation of the patient having an allergy , unintentional use error (patient condition) likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
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Search Alerts/Recalls
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