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 intravenously into the horses' vein resulting in incomplete therapy.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).
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 intravenously into the horses' vein resulting in incomplete therapy.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).The customer returned one single-lumen midline catheter for analysis.Signs of use were observed on and within the returned catheter.Visual analysis revealed the extension line was separated adjacent to the juncture hub.Microscopic examination revealed the edges of the separation were rough and jagged, and a portion of the extension line remained within the juncture hub.The juncture hub was cross-sectioned to analyze the molding of the extension line within the juncture hub.The outer diameter of the line measured 0.094", which is within the specification limits of 0.093"-0.097" per extension line extrusion product drawing.The inner diameter of the extension line measured 0.058", which is within the specification limits of 0.055"-0.059" per extension line extrusion product drawing.Manufacturing was contacted as a part of this complaint investigation.They stated it is unknown whether the defect is related to the molding or the extrusion process; therefore, a non-conformance will be initiated to further investigate this issue.A device history record review was performed, and no relevant findings were identified.The instructions-for-use provided with this 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 a separated extension line was confirmed through complaint investigation of the returned sample.Visual and functional analysis revealed that the extension line was separated adjacent to the juncture hub, the edges of the separation were rough and jagged, and a portion of the extension line remained within the juncture hub.Despite this, the catheter passed all relevant dimensional requirements , and a device history record review revealed no relevant findings to suggest a manufacturing related issue.Based on these circumstances, manufacturing likely caused or contributed to this event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on reports of this nature.

• 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: 21421911
• Report Number: 3006425876-2025-00206
• Device Sequence Number: 20829881
• 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