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	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "(b)(6) 2025 , the inpatient had a central venous line (double lumen) placed in the ultrasound department, and during the postoperative ward nursing operation, it was noted that the secondary line was able to be withdrawn and injected but not fluently, and the primary line was withdrawn and injected very fluently.There was a blockage in the access to the secondary line, which was not functioning properly." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The actual device was not returned; however, the customer provided one photo for evaluation.The 2-lumen catheter was observed in use on a patient with medication flowing through the distal extension line.The proximal extension line had the slide clamp activated and was not being used.No signs of leaking or damage were observed on the catheter.A complete visual inspection 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, "warning: open slide clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure.".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 "on (b)(6) 2025, the inpatient had a central venous line (double lumen) placed in the ultrasound department, and during the postoperative ward nursing operation, it was noted that the secondary line was able to be withdrawn and injected but not fluently, and the primary line was withdrawn and injected very fluently.There was a blockage in the access to the secondary line, which was not functioning properly.".There was no patient harm or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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22332206
• Report Number: 3006425876-2025-00579
• Device Sequence Number: 8300651
• Product Code: DQY
• UDI-Device Identifier: 00801902105455
• UDI-Public: (01)00801902105455(11)240423(17)290331(10)71F24D0459(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): 06/06/2025

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
• Device Catalogue Number: CV-17702-E
• Device Lot Number: 71F24D0459
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2024
• 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