MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 3-LUMEN 7 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CA-22703
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Adult Respiratory Distress Syndrome (1696); Anaphylactic Shock (1703); Cardiac Arrest (1762); Erythema (1840)
Date of Event	09/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient had an allergic reaction to the catheter.The patient had a known allergy to chlorhexidine with previous anaphylaxis to skin prep for peripheral iv 4 months earlier.The patient experienced erythema at the insertion site, respiratory distress with agonal respiration, no pulse, and pulseless electrical activity.The patient was treated with cpr for 45 minutes, epinephrine iv, intubation, cardioversion, and solumedrol.The patient was stabilized and discharged home from the icu after 5 days.It was reported the patient experienced severe psychological distress requiring on-going intervention.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The report of a catheter related allergic reaction was confirmed based on the customer report.The customer confirmed that the patient had a known allergy to chlorexidine and the catheter was inadvertently placed.The instructions for use (ifu), which is included in the device packaging, was reviewed.It states, "contraindications: the arrowg+ard blue antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine and/or sulfa drugs." additionally, 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." a device history record review was performed based on a potential lot from sales history and no relevant findings were identified.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.
Event or Problem Description
It was reported the patient had an allergic reaction to the catheter.The patient had a known allergy to chlorhexidine with previous anaphylaxis to skin prep for peripheral iv 4 months earlier.The patient experienced erythema at the insertion site, respiratory distress with agonal respiration, no pulse, and pulseless electrical activity.The patient was treated with cpr for 45 minutes, epinephrine iv, intubation, cardioversion, and solumedrol.The patient was stabilized and discharged home from the icu after 5 days.It was reported the patient experienced severe psychological distress requiring on-going intervention.

• Brand Name: ARROW CVC KIT: 3-LUMEN 7 FR X 16 CM
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17562993
• Report Number: 9680794-2023-00622
• Device Sequence Number: 15119675
• Product Code: FOZ
• UDI-Device Identifier: 00801902007858
• UDI-Public: 00801902007858
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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?: Yes
• Device Catalogue Number: CA-22703
• Device Lot Number: UNKNOWN
• 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: 08/10/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 10/04/2023
• 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: Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Unknown