MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 16 GA X 6"; CATHETER, PERCUTANEOUS

Catalog Number	CS-04306-EJ
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "the extension line was torn during placement of the catheter.Therefore, the catheter was removed and replaced with a new one.No harm to the patient occurred.The extension line appeared to have been cut by some sharp blade visually." there was no medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported, "the extension line was torn during placement of the catheter.Therefore, the catheter was removed and replaced with a new one.No harm to the patient occurred.The extension line appeared to have been cut by some sharp blade visually." there was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4) the customer returned one, single-lumen catheter for analysis.Signs of use were observed on and within the catheter.Visual analysis revealed the extension line was separated/cut towards the middle of the extrusion.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 32 mm from the juncture hub.The extension line outer diameter measured 2.21 mm, which is within the specification limits of 2.13-2.21 mm per extension line extrusion product drawing.The extension line inner diameter measured 1.47 mm, which is within the specification limits of 1.42-1.50 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 middle.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 (contact with sharps) likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: ARROW CVC SET: 16 GA X 6"
• 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: 22144019
• Report Number: 3006425876-2025-00505
• Device Sequence Number: 12815948
• Product Code: DQY
• UDI-Device Identifier: 00801902104625
• UDI-Public: (01)00801902104625(11)231115(17)281031(10)71F23L0167(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/13/2025

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 Catalogue Number: CS-04306-EJ
• Device Lot Number: 71F23L0167
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• 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