MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH KIT: 20 GA X 1 1/2IN (3.81 CM); WIRE, GUIDE, CATHETER

Catalog Number	ASK-04120-HF3
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "tubing did not give accurate bp reading.They grabbed some separate tubing to complete the procedure".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).The customer returned one tubing and stopcock assembly and a lidstock for analysis.The arterial catheter involved with the complaint was not returned.No obvious signs of use were observed.Visual analysis did not reveal any kinks or defects on the tubing or the stopcock.A full visual analysis could not be performed on the arterial catheter involved with this complaint as it was not returned.The tubing outer diameter measured 0.130", which is within the specification limits of 0.126"-0.130" per the tubing extrusion product drawing.The inner diameter could not be accurately measured due to the tubing design and without permanently damaging the extrusion.A full dimensional analysis could not be performed on the arterial catheter as it was not involved with this complaint as it was not returned.The tubing/stopcock assembly was attached to a lab inventory 20ga arterial catheter.Two separate flush tests were performed by attaching a lab inventory syringe filled with water to the entry ports on the stopcock.With the valve of the stopcock positioned accordingly, the syringe was flushed.No blockages or resistance was observed as the fluid flushed as intended.Performed per ifu statement, "attach stopcock, injection cap or connecting tubing to catheter hub".Per (b)(4), "there shall be no liquid leakage in the form of a falling drop of water when tested at 300-320 kpa (43.5-46.4 psi) for 30 seconds".The stopcock-end of the tubing was connected to a leak tester and pressurized to 320kpa for 30 seconds.No leaks were observed.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "maintain catheter patency according to institutional policies, procedures and practice guidelines".The ifu also states, "to reduce the risk of damage to extension line from excessive pressure, each clamp must be opened prior to infusion through that lumen to prevent any possible adverse affects on monitoring capabilities".The report of an incorrect arterial pressure reading could not be determined as part of this complaint.Visual , dimensional and functional analysis of the returned tubing and stopcock did not reveal any obvious defect or anomalies.The catheter from the reported event was not returned, however, functional testing with a lab inventory 20ga catheter did not reveal any obvious blockages or resistance.A device history record review did not reveal any relevant findings.Based on the customer report and the returned sample, no problem was found with the returned tubing; however, the root cause cannot be determined without the actual arterial catheter also returned for analysis.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "tubing did not give accurate bp reading.They grabbed some separate tubing to complete the procedure".There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW RA CATH KIT: 20 GA X 1 1/2IN (3.81 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: 23532477
• Report Number: 9680794-2025-00913
• Device Sequence Number: 9140909
• Product Code: DQX
• UDI-Device Identifier: 10801902200447
• UDI-Public: (01)10801902200447(11)250303(17)261212(10)33S24C0854(21)
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• 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): 10/15/2025

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 Catalogue Number: ASK-04120-HF3
• Device Lot Number: 33S24C0854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2025
• 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