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	01/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that "the doctor found the extension line leak during used on the patient.They changed a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required".
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one video for analysis.The video confirmed the extension line leak complaint.Fluid is seen leaking while injecting through the extension line luer hub, however, a complete visual inspection to determine the cause of the leak could not be performed as no sample was returned for analysis.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 customer report of the extension line leaking was confirmed by visual inspection of the customer supplied video.The provided video shows fluid leaking while injecting through the extension line luer hub , however, full complaint verification testing to evaluate the cause of the leak could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "the doctor found the extension line leak during used on the patient.They changed a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was 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: 21217782
• Report Number: 3006425876-2025-00059
• Device Sequence Number: 14332120
• Product Code: DQY
• UDI-Device Identifier: 10801902122756
• UDI-Public: (01)10801902122756(11)240514(17)290430(10)71F24E0392(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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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: ES-04301
• Device Lot Number: 71F24E0392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2024
• 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