MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN919469
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the venous line also broke near the insertion hub." the catheter was replaced.There were no consequences to the patient.The patient's current condition is reported as "passed away due to their overall clinical condition, unrelated to the incident".
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "the venous line also broke near the insertion hub." the catheter was replaced.There were no consequences to the patient.The patient's current condition is reported as "passed away due to their overall clinical condition, unrelated to the incident".
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided two photos for analysis.The photos show the medial extension line with a hole in the connection adjacent to the juncture hub; however, a complete visual inspection to determine the cause of the damage could not be performed as no sample was returned for analysis.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." without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "the venous line also broke near the insertion hub." the catheter was replaced.There were no consequences to the patient.The patient's current condition is reported as "passed away due to their overall clinical condition, unrelated to the incident".
Additional Manufacturer Narrative
Qn# (b)(4).The customer provided two images for analysis.Visual analysis confirmed a hole on one of the extension lines adjacent to the juncture hub.The customer also returned one, 3-lumen cvc for analysis.Signs of use were observed inside the extension lines.Visual analysis revealed a hole on the medial extension line adjacent to the juncture hub.Microscopic examination confirmed the damage and revealed that the edges were rough and jagged.The medial line outer diameter measured 4.06mm, which is within the specification limits of 4.04mm-4.14mm per the extension line extrusion product drawing.The medial line inner diameter from within the luer hub measured 2.9464mm (0.116") , which is within the specification limits of 2.900mm-3.000mm per the extension line extrusion product drawing.A lab inventory syringe filled with water was attached to all three extension lines and flushed.When flushing the medial line, water was observed leaking from the hole adjacent to the juncture hub.Performed per ifu statement, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s).".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs 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 report of a leaking extension line was confirmed through analysis of the returned sample.Visual analysis confirmed a leak on the medial extension line directly adjacent to the juncture hub.Despite the damage, the sample met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report, the sample received, and the comments from the manufacturing site, the likely root cause is manufacturing related.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 16 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: 23617364
• Report Number: 3006425876-2025-01093
• Device Sequence Number: 8977889
• Product Code: FOZ
• UDI-Device Identifier: 10801902219203
• UDI-Public: (01)10801902219203(11)250826(17)300731(10)71F25H0830(21)
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K970864
• 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): 10/30/2025

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: IPN919469
• Device Catalogue Number: CV-12123-F
• Device Lot Number: 71F25H0830
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 12/15/2025; 01/22/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/19/2025; 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2025
• 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; NOT REPORTED
• Patient Sex: Unknown