MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 5 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	ES-04301
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the extension line was found leak during used on the patient".They changed a new one to resolve the issue.The patient condition is fine and had no harm or injury.A medical intervention was not required.
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one, opened cvc kit including one, single-lumen catheter for analysis.Signs of use were observed on and within the catheter.Visual analysis did not reveal any defects or anomalies on the returned catheter.The extension line outer diameter measured 2.15 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 1.50 mm, which is within the specification limits of 1.42-1.50 mm per extension line extrusion product drawing.The catheter body length from the juncture hub to the distal tip measured 208 mm, which is within the specification limits of 201.5-210.5 mm per catheter product drawing.The catheter was functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." a lab inventory syringe filled with water was attached to the extension line.The extension line flushed as intended with sign of a leak.The returned catheter was then tested per bs en iso 10555-1 section 4.7.1 (amrq-000071 rev.15) which states that there shall be no liquid leakage in the form of one or more falling drops when pressurized to 300 kpa for 30 seconds.The device was connected to a lab leak tester and pressurized to 300 kpa for 30 seconds with the distal end occluded.The extension line was connected to the leak tester, and when pressurized, no catheter backflow or leaks were detected from any portion of the catheter.Based on this testing, the customer issue could not be reproduced with the returned sample.A manual tug test confirmed the lumen was secured to its hub.A device history record review was performed, and no relevant findings were identified.The 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 customer report of an extension line leak was not confirmed through complaint investigation of the returned sample.The catheter met all relevant dimensional requirements, and passed functional leak testing performed per iso 10555-1 with no evidence of leakage or backflow.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the testing of the sample received, no problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "the extension line was found leak during used on the patient".They changed a new one to resolve the issue.The patient condition is fine and had no harm or injury.A medical intervention was not required.

• Brand Name: ARROW CVC SET: 5 FR X 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: 20962053
• Report Number: 3006425876-2024-01230
• Device Sequence Number: 8195860
• Product Code: DQY
• UDI-Device Identifier: 10801902122756
• UDI-Public: (01)10801902122756(11)230313(17)280229(10)71F23C0515(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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: ES-04301
• Device Lot Number: 71F23C0515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2023
• 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
• Patient Sex: Unknown