MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 1-LUMEN 5 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	AK-04301-J
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "that the swg tip was found deformed when the user attempted to use it during the procedure.Therefore, a new kit was used to complete the procedure.No injury to the patient occurred." there was no medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "that the swg tip was found deformed when the user attempted to use it during the procedure.Therefore, a new kit was used to complete the procedure.No injury to the patient occurred." there was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one opened cvc kit containing a guidewire with its advancer and an arrow raulerson syringe (ars) attached to the 18ga introducer needle.Signs of use were observed on the returned components.Visual inspection revealed that the distal j-bend of the guidewire was misshapen, and a single kink was observed on the guidewire body near the j-bend.Both welds at the distal end were present, spherical, and showed no visible abnormalities.Excess biological material was noted on the needle hub and within the needle cannula.The ars displayed no visible defects or surface anomalies.The kink in the guide wire measured 575 mm from the proximal tip.The overall length of the guide wire measured 602 mm, which is within the specification limits of 596-604 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.798 mm, which is within the specification limits of 0.788-0.826 mm per guide wire product drawing.The outer diameter of the needle cannula measured 0.0499" which is within the specification limits of 0.0495"-0.0505" per needle cannula product drawing.The inner diameter of the needle cannula measured 0.041", which is within the specification limits of 0.041"-0.043" per needle cannula product drawing.The guide wire and introducer needle were functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was advanced through the returned ars and 18ga introducer needle.The guide wire passed through both components with little to no resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed, and no relevant manufacturing issues were identified.The ifu provided with the kit informs the user, "advancement of guidewire through arrow raulerson syringe may require a gentle twisting motion.Do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage." the report of a guide wire/needle resistance with a kinked guide wire was confirmed through complaint investigation of the returned sample.One kink on the guidewire body and a misshapen distal j-bend.Biological material was present in the needle hub and within the needle cannula.Since the customer reported the resistance during use, this suggests the excess biological material resulted in the use of undue force resulting in the kinking in the guide wire.The guidewire and introducer needle met all applicable dimensional and functional specifications.A device history record review did not identify any manufacturing related issues.Based on the customer report and the sample received, unintentional use error along with needle blockage due to biological material likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC KIT: 1-LUMEN 5 FR X 20 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: 23631692
• Report Number: 3006425876-2025-01115
• Device Sequence Number: 16030901
• Product Code: DQY
• UDI-Device Identifier: 30801902169076
• UDI-Public: (01)30801902169076(11)221020(17)260428(10)71F22K2096(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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 Expiration Date: 04/28/2026
• Device Catalogue Number: AK-04301-J
• Device Lot Number: 71F22K2096
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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