MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number	CDC-21242-XCN1A
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Anaphylactic Shock (1703); Low Blood Pressure/ Hypotension (1914); Urinary Retention (2119); Renal Impairment (4499); Angioedema (4536)
Date of Event	02/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Uf/importer report # (b)(4).
Event or Problem Description
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.".
Event or Problem Description
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.".
Additional Manufacturer Narrative
(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.

• Brand Name: ARROW MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17479789
• Report Number: 9680794-2023-00594
• Device Sequence Number: 2711972
• Product Code: FOZ
• UDI-Device Identifier: 10801902179286
• UDI-Public: 10801902179286
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K011761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: CDC-21242-XCN1A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Unknown