MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM); WIRE, GUIDE, CATHETER

Catalog Number	ASK-04020-AH
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "on two separate occasions, when using the arrow arterial line with the extension j-loop with the clamp, the flush tubing (edward's product not teleflex) could not be disconnected from the red arterial line.On one occasion nurses attempted to loosen the connection with alcohol wipes and kelly clamps, but the flush tubing cracked and broke, and the art line had to be exchanged.So, the second time this occurred, they left the tubing connected because they did not want it to break." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine" associate mdr numbers include: 9680794-2026-00203 and 9680794-2026-00202.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(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.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "on two separate occasions, when using the arrow arterial line with the extension j-loop with the clamp, the flush tubing (edward's product not teleflex) could not be disconnected from the red arterial line.On one occasion nurses attempted to loosen the connection with alcohol wipes and kelly clamps, but the flush tubing cracked and broke, and the art line had to be exchanged.So, the second time this occurred, they left the tubing connected because they did not want it to break." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine" associate mdr numbers include: 9680794-2026-00203 and 9680794-2026-00202.

• Brand Name: ARROW RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: 24674443
• Report Number: 9680794-2026-00202
• Device Sequence Number: 10139339
• Product Code: OFB
• UDI-Device Identifier: 10801902114898
• UDI-Public: (01)10801902114898(11)250529(17)260731(10)33F25D0332(21)
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: ASK-04020-AH
• Device Lot Number: 33F25D0332
• 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: 02/27/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2025
• 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