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	02/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the extension line of four devices separated during intravenous infusion of iv fluids on four different horses in a veterinary clinic.The iv fluids were unable to be delivered completely into the horses' vein.The device was removed and replaced.The incident did not cause any harm, injury or sustaining health consequences to the animals.The associated emdr report numbers are 3006425876-2025-00190, 3006425876-2025-00207, 3006425876-2025-00206 and 3006425876-2025-00205.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer provided six photos for analysis.The photos show the distal extension line separated adjacent to the luer hub and portions of the extension line extrusion were within the luer hub.The report of extension line/luer hub separation was confirmed from the customer provided photos.The damage is consistent with a manufacturing molding issue.The customer returned one representative cvc kit for analysis.No defects or anomalies were observed with the returned sample.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 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/luer hub separation was confirmed through visual analysis of the customer photos.The customer returned a representative sample; however, visual analysis of the customer photos revealed that the distal line had separated directly adjacent to the luer hub, and portions of the extension line remained within the luer hub.The damage is consistent with a manufacturing molding issue.Based on the information provided and the customer photos, manufacturing molding likely caused or contributed to this event.A capa has previously been initiated 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 (july and august 2022) involved with this complaint.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that the extension line of four devices separated during intravenous infusion of iv fluids on four different horses in a veterinary clinic.The iv fluids were unable to be delivered completely into the horses' vein.The device was removed and replaced.The incident did not cause any harm, injury or sustaining health consequences to the animals.The associated emdr report numbers are 3006425876-2025-00190, 3006425876-2025-00207, 3006425876-2025-00206 and 3006425876-2025-00205.

• 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: 21421900
• Report Number: 3006425876-2025-00190
• Device Sequence Number: 7987127
• Product Code: DQY
• UDI-Device Identifier: 00801902105165
• UDI-Public: (01)00801902105165(11)221005(17)270228(10)71F22J3287(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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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 Catalogue Number: CV-04301
• Device Lot Number: 71F22J3287
• 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: 02/10/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2022
• 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