MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 16 GA X 8IN (20 CM); CATHETER PERCUTANEOUS

Catalog Number	CV-04301
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a nurse at a veterinary clinic, "the connection piece to the hose is apparently broken." another kit was used in the other arm.There was no patient harm or injury.The patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one, single-lumen cvc catheter for analysis.Signs of use were observed.Visual and microscopic analysis revealed the extension line was separated from the luer hub, and a portion of the extension line was visible within the luer hub.The extension line appeared rough and jagged at the point of separation.The outer diameter of the extension line measured 2.16 mm, which is within the specification limits of 2.13-2.21 mm per extension line extrusion product drawing.The inner diameter of the extension line measured 1.45 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 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 report of extension line/luer hub separation was confirmed through complaint investigation of the returned sample.Visual and microscopic analysis revealed the extension line was separated from the luer hub, and portions of the extension line were visible within the luer hub.The extension line appeared rough and jagged at the point of separation.Based on the appearance of the damage, manufacturing caused or contributed to this event.A capa has previously been implemented to address issues of this nature and indicates that the root cause is manufacturing related.This capa was implemented 07-nov-2024 to address the issue of extension line/luer hub separation.This implementation date occurred after the manufacturing date of the extension lines ((b)(6) 2024) involved with this complaint.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported by a nurse at a veterinary clinic, "the connection piece to the hose is apparently broken." another kit was used in the other arm.There was no patient harm or injury.The patient's current condition is reported as "unknown".

• Brand Name: ARROW CVC SET: 16 GA X 8IN (20 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: 21772070
• Report Number: 3006425876-2025-00323
• Device Sequence Number: 9821327
• Product Code: DQY
• UDI-Device Identifier: 00801902105165
• UDI-Public: (01)00801902105165(11)241121(17)290430(10)71F24L0307(21)
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K862056
• 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): 03/14/2025

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: CV-04301
• Device Lot Number: 71F24L0307
• 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: 03/14/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2024
• 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