MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-25123-F
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "when attempting to separate the infusion end and infusion sleeve of the triple-lumen catheter, the tubing broke, making the tubing unusable.Additionally, the tubing's seal needs to be reinforced to prevent blood loss from the patient through the broken tubing." the user changed to a new set to resolve the issue.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "when attempting to separate the infusion end and infusion sleeve of the triple-lumen catheter, the tubing broke, making the tubing unusable.Additionally, the tubing's seal needs to be reinforced to prevent blood loss from the patient through the broken tubing." the user changed to a new set to resolve the issue.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The customer also returned one, 3-lumen catheter for analysis.Signs of use in the form of biological material were observed on and within the catheter.Visual analysis revealed the distal extension line was separated/cut towards the luer hub.Microscopic analysis confirmed the damage, and the edges of the cut appeared smooth and uniform which is consistent with contact with a sharp instrument (i.E.Scissors, scalpel , etc.).The cut in the extension line measured 49 mm from the juncture hub.The extension line outer diameter measured 1.70 mm, which is within the specification limits of 1.68-1.78 mm per extension line extrusion product drawing.The extension line inner diameter measured 1.22 mm, which is within the specification limits of 1.14-1.24 mm per extension line extrusion product drawing.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 customer report of an extension line leak was confirmed through complaint investigation of the returned sample.Visual inspection revealed the extension line was cut towards the luer hub.The edges of the cut were smooth and appeared consistent with contact with a sharp instrument (i.E.Scalpel, scissors, etc.).The catheter met all relevant dimensional requirements.A device history record review was performed, and no relevant findings were identified.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 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: 22437476
• Report Number: 3006425876-2025-00614
• Device Sequence Number: 3238037
• Product Code: FOZ
• UDI-Device Identifier: 00801902102300
• UDI-Public: (01)00801902102300(11)240308(17)260119(10)71F24B1653(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,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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: 01/19/2026
• Device Catalogue Number: CS-25123-F
• Device Lot Number: 71F24B1653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2024
• 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