MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 14 GA X 6" (16 CM); CATHETER PERCUTANEOUS

Catalog Number	CS-24706-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "(b)(6) 2025, after inserting the catheter, the patient had an allergic reaction." additional information received reports "the allergic reaction was caused by chlorohexidine".The user changed a new set to resolve the issue.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "(b)(6) 2025,after inserting the catheter, the patient had an allergic reaction." additional information received reports "the allergic reaction was caused by chlorohexidine".The user changed a new set to resolve the issue.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(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 complaint of a catheter-related allergic reaction is confirmed based on the additional information provided.The customer confirmed that the adverse reaction was associated with the chlorhexidine coating on the catheter.The instructions for use (ifu) provided with this kit warns the user, "contraindications: the arrowg+ard blue antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine and/or sulfa drugs.Hypersensitivity reactions are a concern with antimicrobial catheters in that they can be very serious and even life-threatening.Remove catheter immediately if adverse reactions occur after catheter placement.".Based on the available information, the complaint has been confirmed and unintentional use error related to the patient's condition likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 14 GA X 6" (16 CM)
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21771661
• Report Number: 3006425876-2025-00330
• Device Sequence Number: 8199777
• Product Code: DQY
• UDI-Device Identifier: 10801902102291
• UDI-Public: (01)10801902102291(11)240321(17)260228(10)71F24C0792(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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 Expiration Date: 02/28/2026
• Device Catalogue Number: CS-24706-E
• Device Lot Number: 71F24C0792
• 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: 03/13/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2024
• 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
• Patient Sex: Unknown