MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 25 CM; CATHETER PERCUTANEOUS

Model Number	IPN919642
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the third lumen connection came off completely." the patient's current condition is reported as "unknown".Additional information was requested from the customer; however, further details have not been provided at this time.
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The photo shows the distal extension line separated towards the luer hub, and the separated end of the extension line appeared jagged.A device history record review was performed, and there was one potential finding.A non-conformance was initiated for lot 72c24d0243 to address the issue "disconnected connector on the extension tube." the failure mode of this complaint is the same as/relevant to the non-conformance 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." the customer report of extension line/luer hub separation was confirmed by visual inspection of the customer supplied photo.The distal extension line was separated towards the luer hub, and the separated end of the extension line appeared jagged.The observed defect appears consistent with a manufacturing molding defect.Based on these circumstances, manufacturing likely caused or contributed to the reported event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "the third lumen connection came off completely." the patient's current condition is reported as "unknown".Additional information was requested from the customer; however, further details have not been provided at this time.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 25 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: 23132625
• Report Number: 3006425876-2025-00877
• Device Sequence Number: 15931915
• Product Code: DQY
• UDI-Device Identifier: 00801902099679
• UDI-Public: (01)00801902099679(11)240919(17)290831(10)71F24J0477(21)
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/28/2025

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 Model Number: IPN919642
• Device Catalogue Number: CS-16123-F
• Device Lot Number: 71F24J0477
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2024
• 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