MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET:20 GA CATH/22 GA NDL; WIRE GUIDE CATHETER

Catalog Number	FA-04020
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the arterial line dressing was soaked with blood, and it appeared that there is a split in the catheter.The line was removed from the patient and quarantined.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported that "the arterial line dressing was soaked with blood, and it appeared that there is a split in the catheter.The line was removed from the patient and quarantined.".
Event or Problem Description
It was reported that "the arterial line dressing was soaked with blood, and it appeared that there is a split in the catheter.The line was removed from the patient and quarantined.".
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one arterial catheter for analysis.Signs of use in the form of biological material were observed on the catheter hub.Visual analysis did not reveal any defects or anomalies with the returned sample.The catheter body total length from the hub (proximal end) to the distal tip measured 4" , which is close to the reference dimension of 4.062" per catheter graphic.The catheter body outer diameter measured 0.0449", which is within the specification limits of 0.044" - 0.046" per the catheter extrusion graphic.The catheter body inner diameter at the proximal end measured 0.032", which is within the specification limits of 0.031" - 0.033" per the catheter extrusion graphic.A lab inventory luer-lock syringe filled with water was attached to the catheter hub.The plunger was flushed , and no leaks were observed.The returned catheter was then tested per bs en iso 10555-1 section 4.7.1, which states that there shall be no liquid leakage in the form of one or more falling drops when pressurized to 300 kpa for 30 seconds.The device was connected to a lab leak tester and pressurized to 300 kpa for 30 seconds with the distal end occluded.No leaks were detected from any portion of the catheter.Based on this testing, the customer issue could not be reproduced with the returned sample.To check for blockages, a lab inventory guidewire with a diameter of 0.018" was inserted through the returned catheter.The guidewire was able to pass completely through the assembly with little to no difficulty.A device history record review was performed with no relevant findings.The ifu provided with the kit informs the user, "hold catheter in place and remove spring-wire guide assembly.Pulsatile blood flow indicates positive arterial placement." the ifu also states, "attach stopcock, injection cap or connecting tubing to catheter hub.Secure catheter to patient in preferred manner using suture wings, suture groove or wing clip, where provided.Warning: care should be exercised that the catheter is not inadvertently kinked at the hub area when securing catheter to the patient as this may result in catheter damage, breakage and loss of arterial monitoring capabilities." the report of a split arterial catheter was not confirmed through complaint investigation.Visual analysis did not reveal any defects or anomalies and the catheter passed functional leak testing when tested in accordance per iso 10555-1.Additionally, the catheter met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, no problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW ARTERIAL CATH SET:20 GA CATH/22 GA NDL
• 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: 21731003
• Report Number: 9680794-2025-00244
• Device Sequence Number: 4046371
• Product Code: DQX
• UDI-Device Identifier: 00801902100603
• UDI-Public: (01)00801902100603(11)240514(17)290430(10)13F24E0007(21)
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: FA-04020
• Device Lot Number: 13F24E0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2025
• Supplement Date Received by Manufacturer: 04/09/2025; 08/12/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 04/17/2025; 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• 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; NOT REPORTED
• Patient Sex: Unknown