MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	CV-17702-E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The report of an insertion site leak was not confirmed through analysis of the returned sample.Visual, dimensional, and functional analyses of the returned catheter confirmed no issues, and a device history record review was performed did not reveal any findings; however, it was noted that a section of the catheter body was severed and not returned by the customer.Per the kit instructions-for-use (ifu), catheters of this type are not intended to be severed during use.Based on the customer report and the sample received, no problem was found with the returned device; however, the root cause cannot be determined at this time without the separated portion of the catheter returned.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "(b)(6) 2026,leakage occurred at the puncture site during infusion via the measuring lumen catheter, which made it impossible to ensure the actual dose of the infused drug entering the patient's body and increased the risk of infection for the patient.The patient underwent catheter removal; re-catheterization was not required.The patient had a double-lumen cvc catheter indwelled on (b)(6) 2025." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "(b)(6) 2026, leakage occurred at the puncture site during infusion via the measuring lumen catheter, which made it impossible to ensure the actual dose of the infused drug entering the patient's body, and increased the risk of infection for the patient.The patient underwent catheter removal; re-catheterization was not required.The patient had a double-lumen cvc catheter indwelled on (b)(6) 2025." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC SET: 2-LUMEN 7 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24661351
• Report Number: 3006425876-2026-00323
• Device Sequence Number: 5042640
• Product Code: DQY
• UDI-Device Identifier: 10801902183771
• UDI-Public: (01)10801902183771(11)240924(17)290831(10)71F24J0704(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): 02/27/2026

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
• Device Catalogue Number: CV-17702-E
• Device Lot Number: 71F24J0704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2024
• 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