MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 30 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-24703-E
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn(b)(4).
Event or Problem Description
It was reported "the luer-hub(browen) broken." additional information received reports "when the nurse was turning the patient over, found that the luer-hub (brown)had broken and fallen off, so clamped it with a kelly hemostatic forceps." the device was removed and replaced.There was no patient harm or or injury.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "the luer-hub(browen) broken." additional information received reports "when the nurse was turning the patient over, found that the luer-hub (brown)had broken and fallen off, so clamped it with a kelly hemostatic forceps." the device was removed and replaced.There was no patient harm or or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The customer provided two photos for analysis.The photos show the distal extension line with the luer hub missing.The customer returned one, 3-lumen cvc catheter for analysis.Signs of use in the form of biological material were observed, and the distal end was intentionally severed.Visual and microscopic analysis revealed the distal extension line was separated from the luer hub , the distal luer hub was not returned.The extension line appeared rough and jagged at the point of separation.Without the separated luer hub returned, the nature of the fracture cannot be confirmed.The outer diameter of the distal extension line measured 2.13 mm, which is within the specification limits of 2.13-2.21 mm per distal extension line extrusion product drawing.The inner diameter of the distal extension line measured 1.47 mm, which is within the specification limits of 1.42-1.50 mm per distal extension line extrusion product drawing.A manual tug test confirmed the other extension lines were secure and intact within their respective luer hubs.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 distal extension line was separated from the luer hub; however, the distal luer hub was not returned.The extension line appeared rough and jagged at the point of separation; however, the nature of the fracture cannot be confirmed without the separated luer hub returned for evaluation.Based on the appearance of the customer report and the sample received, the root cannot be determined without the luer hub returned.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 30 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: 21889365
• Report Number: 3006425876-2025-00378
• Device Sequence Number: 11623645
• Product Code: FOZ
• UDI-Device Identifier: 00801902102287
• UDI-Public: (01)00801902102287(11)240529(17)260422(10)71F24E0580(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): 03/28/2025

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 Expiration Date: 04/22/2026
• Device Catalogue Number: CS-24703-E
• Device Lot Number: 71F24E0580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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