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

Catalog Number	CS-22123-F
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#:(b)(4).
Event or Problem Description
It was reported "one of set luer-hub broken.One of set guide wire broken." additional information received from the customer states the luer hub was " separated from the extension line".The device was removed and replaced.There was no patient harm or injury.The patient's current condition is reported as "fine".Associated mdr numbers include:3006425876-2025-00376 and 3006425876-2025-00375.
Additional Manufacturer Narrative
(b)(4).The customer returned one, 3-lumen cvc for analysis.Signs of use in the form of biological material were observed inside the catheter body.Visual analysis revealed that the distal extension line was separated.The point of separation was located at the juncture hub; however, a portion of the extension line was still molded within the juncture hub.Microscopic examination confirmed the separation and revealed that the edges were rough/jagged.Further analysis also revealed that the distal line extrusion was narrowed, which is indicative that undue force resulted in the line becoming stretched.In an area where narrowing was observed, the outer diameter of the distal line measured 1.43mm, which is below the specification limits of 1.68mm-1.78mm per the distal extension line extrusion product drawing.The inner diameter in an area of observed narrowing measured 0.9906mm, which is not within the specification limits of 1.14mm-1.24mm per the distal extension line extrusion product drawing.In an area where no narrowing was observed, the outer diameter of the distal line measured 1.69mm, which is within the specification limits of 1.68mm-1.78mm per the distal extension line extrusion product drawing.The inner diameter in an area where no narrowing was observed measured 1.168mm , which is within the specification limits of 1.14mm-1.24mm per the distal extension line extrusion product drawing.The discrepancies with the outer and inner diameters measuring below the specification limits confirm that the extrusion was narrowed due to stretching.A manual tug test confirmed that the distal line was secure within the brown luer hub.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "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 an extension line/juncture hub separation was confirmed through investigation of the returned sample.Visual analysis revealed that the distal line was separated from the juncture hub; however, a portion of the extrusion was still molded within the juncture hub.Visual analysis also revealed that a section of the separated line was narrowed and appeared stretched.Dimensional analysis confirmed that this narrowed section measured below the specification limits which indicates that the extension line was stretched prior to fracturing.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "one of set luer-hub broken.One of set guide wire broken." additional information received from the customer states the luer hub was " separated from the extension line".The device was removed and replaced.There was no patient harm or injury.The patient's current condition is reported as "fine".Associated mdr numbers include:3006425876-2025-00376 and 3006425876-2025-00375.

• 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: 21847192
• Report Number: 3006425876-2025-00375
• Device Sequence Number: 20824022
• Product Code: FOZ
• UDI-Device Identifier: 00801902102188
• UDI-Public: (01)00801902102188(11)240213(17)260103(10)71F24B0784(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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: 01/03/2026
• Device Catalogue Number: CS-22123-F
• Device Lot Number: 71F24B0784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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