MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 20CM; CATHETER, PERCUTANEOUS

Model Number	IPN918561
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "when changing the cvc lines, the lines were clamped so that the old lines could be unscrewed and replaced with new ones.While doing this, one of the catheter hubs broke off completely." the patient's current condition is reported unknown at this time.
Additional Manufacturer Narrative
(b)(4).The customer returned a 4-lumen catheter and a 3-way stopcock for analysis.Signs of use in the form of biological material were observed on and within the catheter.Visual analysis revealed the 18ga medial 2.Extension line luer hub was separated and not returned.The perimeter of the point of separation on the extension line extrusion appeared smooth and uniform on one side, then rough and jagged on the other.A complete visual analysis to evaluate the nature of the separation could not be performed without the separated luer hub returned for analysis.The distal end of the catheter body appeared intentionally cut.The catheter body length measured 126mm, which is not within the specification limits of 207mm - 227mm per the catheter product drawing.It was calculated that the customer intentionally trimmed approximately 81mm - 101mm off the distal end.The outer diameter of the catheter body measured 2.89mm, which is within the specification limits of 2.87mm - 2.97mm per the catheter extrusion product drawing.The medial 2 extension line measured 114mm from the juncture hub to the point of separation.The outer diameter of the medial 2 extension line measured 2.14mm, which is within the specification limits of 2.13mm - 2.21mm per the medial 2 extension line extrusion product drawing.The inner diameter of the medial 2 extension line measured 1.4478mm, which is within the specification limits of 1.42mm - 1.50mm per the medial 2 extension line extrusion product drawing.A manual tug test confirmed the remaining three luer hubs were secure and intact.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations.Do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." the report of extension line/luer hub separation was confirmed through complaint investigation of the returned sample.Visual analysis confirmed the medial 2 extension line was separated from the luer hub; however, the luer hub was not returned.The separation point on the extension line appeared smooth and uniform on one side, then rough and jagged on the other.A complete visual analysis to evaluate the nature of the separation could not be performed without the luer hub returned for analysis.A device history record review was performed, and no relevant findings were identified.Based on these circumstances, the probable cause could not be determined without the separated luer hub returned.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "when changing the cvc lines, the lines were clamped so that the old lines could be unscrewed and replaced with new ones.While doing this, one of the catheter hubs broke off completely." the patient's current condition is reported unknown at this time.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 20CM
• 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: 23617554
• Report Number: 3006425876-2025-01095
• Device Sequence Number: 18405063
• Product Code: DQY
• UDI-Device Identifier: 10801902029291
• UDI-Public: (01)10801902029291(11)241122(17)290430(10)71F24L0535(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• 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
• Report Date (Section B): 10/31/2025

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 Model Number: IPN918561
• Device Catalogue Number: CV-15854
• Device Lot Number: 71F24L0535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2024
• 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
• Patient Sex: Unknown