MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-25703-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Rash (2033); Swelling/ Edema (4577)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the defective product caused redness, swelling, and allergic reactions in patients during placement." the symptoms were resolved after removal.The user changed to a new set.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "safe".
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided eight photos for analysis.The pictures show multiple angles of the insertion site, along with the lidstock and tray of the finished good.The complaint of an allergic reaction was able to be confirmed by the photos, which show redness and swelling around the insertion site.It was noted that this cvc is an arrowg+ard blue antimicrobial catheter, which contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine and/or sulfa drugs.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user , "the arrowg+ard blue antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine , silver sulfadiazine and/or sulfa drugs." it also states, "hypersensitivity reactions are a concern with antimicrobial catheters in that they can be very serious and even life-threatening.Since antimicrobial catheters were introduced into the market, there have been reports of hypersensitivity occurrences.This may affect your patient population, especially if your patient is of japanese origin.See the warning section for additional information." the customer report of an allergic reaction was confirmed by visual inspection of the customer supplied photo.The pictures show multiple angles of the insertion site, along with the lidstock and tray of the finished good.The complaint of an allergic reaction was able to be confirmed by the photos, which show redness and swelling around the insertion site.It was noted that this cvc is an arrowg+ard blue antimicrobial catheter , which contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine and/or sulfa drugs.However, the customer did not provide any test results or confirmation that the adverse reaction was specifically associated with the catheter coating agents.The instructions for use (ifu) provided with this kit warns the user, "remove catheter immediately if catheter-related adverse reactions occur after catheter placement.Note: perform sensitivity testing to confirm allergy to catheter antimicrobial agents if adverse reaction occurs".A device history record review was performed, and no relevant findings were identified.Therefore, based on the available information, the complaint could not be confirmed and the probable cause could not be determined.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "the defective product caused redness, swelling, and allergic reactions in patients during placement." the symptoms were resolved after removal.The user changed to a new set.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "safe".

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 24518818
• Report Number: 3006425876-2026-00243
• Device Sequence Number: 8430322
• Product Code: FOZ
• UDI-Device Identifier: 00801902102324
• UDI-Public: (01)00801902102324(11)250306(17)270213(10)71F25B1135(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K900263
• 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): 02/05/2026

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: CS-25703-E
• Device Lot Number: 71F25B1135
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2025
• 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