Medwatch report received: "patient (pt) had multiple known allergies and underwent allergy test following recent anaphylactic reaction after intubation.Surgery cancelled and allergy testing done revealed chg (chlorhexidine gluconate) allergy.Two months later, returned to or.After central line placed - developed hypotension, treated for anaphylaxis.Suspected source central line - chlorhexidine coating.Patient prepped with betadine for both line insertions.Line removed.New non-coated chg inserted.Decision to proceed with surgical procedure.Pt required 125 mg of solu-cortef and had already rec'd decadron for ponv (postoperative nausea and vomiting) prior to anaphylactic episode.".
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Medwatch report received: "patient (pt) had multiple known allergies and underwent allergy test following recent anaphylactic reaction after intubation.Surgery cancelled and allergy testing done revealed chg (chlorhexidine gluconate) allergy.Two months later, returned to or.After central line placed - developed hypotension, treated for anaphylaxis.Suspected source central line - chlorhexidine coating.Patient prepped with betadine for both line insertions.Line removed.New non-coated chg inserted.Decision to proceed with surgical procedure.Pt required 125 mg of solu-cortef and had already rec'd decadron for ponv (postoperative nausea and vomiting) prior to anaphylactic episode.".
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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 instructions for use provided with this kit states, "the arrowg+ard blue antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine acetate , silver sulfadiazine, and/or sulfa drugs." the report of a catheter related allergic reaction was confirmed based on the customer report.The labeling provided with the coated catheter states "the arrowg+ard blue antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine acetate , silver sulfadiazine, and/or sulfa drugs." the patient was confirmed to have a chlorhexidine allergy two months prior to the event.Therefore, based on the reported event and confirmation of the patient having a known allergy, intentional use error (not per ifu) likely caused or contributed to this event.A customer in-service has been requested to further educate the customer.Teleflex will continue to monitor and trend for reports of this nature.
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