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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during the procedure according to ifu, the md found the dilator failed to penetrate the subcutaneous issue.When i checked whether or not to use guidewire, it was said to have been used, and when i took it out, it was said that the guidewire was bent.So, the md opened up the new kit to finish the procedure." additional information received states " according to the user, the guidewire was used during the procedure, and upon removal from the patient's body, it was observed to be bent.The user also reported that the initial attempt was unsuccessful in penetrating the subcutaneous layer, after which a new device was opened and used." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one arrow raulerson syringe, introducer needle, 3-lumen catheter, transduction probe, catheter clamp, clamp fastener, catheter-over-needle, guidewire inside the advancer, and two dust caps for analysis.No defects or anomalies were observed on the returned components.No damage was observed on the guidewire despite the customer report of a kink.No signs of use in the form of biological material were observed on the guidewire or dilator.Microscopic examination confirmed the distal and proximal welds of the guidewire were secure and intact.The overall guidewire length measured 600 mm, which is within the specification limits of 596 mm - 604 mm per the guidewire product drawing.The guidewire outer diameter measured 0.790 mm, which is within the specification limits of 0.788 mm - 0.826 mm per the guidewire product drawing.The inner diameter of the dilator at the distal tip measured.94 mm, which is within the specification limits of.91 mm -.97 mm per the dilator product drawing.The outer diameter of the dilator measured 2.82 mm which is within the specification limits of 2.81 mm - 2.87 mm per the dilator product drawing.The returned guidewire was inserted through the distal tip of the dilator.The guidewire passed with no resistance.Performed per ifu statement, "use tissue dilator to enlarge tissue tract to the vein as required.Follow the angle of the guidewire slowly through the skin".A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage.If necessary, enlarge cutaneous puncture site with cutting edge of scalpel, positioned away from guidewire." the report of a kinked guidewire due to dilator resistance was not confirmed through complaint investigation.No damage was identified on the returned guidewire.The reported guidewire and dilator met all relevant dimensional and functional requirements.A device history record review did not reveal any relevant findings.Based on the customer report and the sample received, no problem was identified.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "during the procedure according to ifu, the md found the dilator failed to penetrate the subcutaneous issue.When i checked whether or not to use guidewire, it was said to have been used, and when i took it out, it was said that the guidewire was bent.So the md opened up the new kit to finish the procedure." additional information recieved states " according to the user, the guidewire was used during the procedure, and upon removal from the patient's body, it was observed to be bent.The user also reported that the initial attempt was unsuccessful in penetrating the subcutaneous layer, after which a new device was opened and used." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• 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: 24131288
• Report Number: 3006425876-2026-00131
• Device Sequence Number: 10387648
• Product Code: FOZ
• UDI-Device Identifier: 00801902102324
• UDI-Public: (01)00801902102324(11)250318(17)270220(10)71F25C0287(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 01/19/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: CS-25703-E
• Device Lot Number: 71F25C0287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2025
• 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