MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 20CM; CATHETER, PERCUTANEOUS

Model Number	IPN918561
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "after insertion of the cvc, 2 out of 4 extension lines were not working: it was impossible to aspirate the line.Cvc changed".
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one 4-l catheter for analysis.Definite signs of use in the form of biological material were observed within the catheter extension lines.Visual analysis of the catheter revealed no obvious defects or anomalies.After performing functional testing, it was revealed that the distal and 14cm medial extension lines had no issues.The 12.7cm medial and proximal extension lines encountered resistance.The customer complaint of 2 extension lines blocked in use was confirmed.Large amounts of biological material were observed within the blocked lumens.The overall length of the catheter measured 218mm, which is within the specification limits of 207mm - 227mm per the catheter product drawing.The outer diameter of the catheter measured 2.92mm , which is within the specification limits of 2.87mm - 2.97mm per the catheter extrusion graphic.The outer diameter of the proximal extension line measured 2.19mm, which is within the specification limits of 2.13mm - 2.21mm per the proximal extension line extrusion drawing.The inner diameter of the proximal extension line measured 1.4732mm, which is within the specification limits of 1.42mm - 1.50mm per the extension line product drawing.The outer diameter of the 12.7cm medial 1 extension line measured 2.17mm , which is within the specification limits of 2.13mm - 2.21mm per the medial 1 extension line extrusion drawing.The inner diameter of the medial 1 extension line measured 1.4478mm , which is within the specification limits of 1.40mm - 1.48mm per the extension line extrusion product drawing.The catheter was functionally tested per the instructions for use (ifu) provided with this kit, which instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the distal and the medial 2 lines flushed as intended.Resistance was experienced when flushing the proximal and medial 1 extension lines, indicating a blockage within the lumens.A long pin gauge was inserted into the proximal lumen to release the blockage, and large amounts of biological material were observed within the lumen.The same method was performed to remove a similar blockage of biological material from the medical 1 extension line.Once removed, both extension lines flushed as intended.A manual tug test confirmed that all four extension lines were secure within their respective hubs.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit informs the user, "maintain catheter patency according to institutional policies, procedures and practice guidelines.All personnel who care for patients with central venous catheters must be knowledgeable about effective management to prolong catheter's dwell time and prevent injury." the customer report of two blocked extension lines was confirmed through investigation of the returned sample.Functional testing revealed a blockage in the proximal and 12.7cm medial extension lines due to biological material.After the lines were cleared of biological material, they flushed as intended.The catheter passed all relevant visual and dimensional inspections, and a device history record review revealed no relevant findings.Therefore, based on the customer report that the blockage was observed during use and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that "after insertion of the cvc, 2 out of 4 extension lines were not working: it was impossible to aspirate the line.Cvc changed".

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 20CM
• 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: 21364552
• Report Number: 3006425876-2025-00146
• Device Sequence Number: 15566152
• Product Code: DQY
• UDI-Device Identifier: 10801902029291
• UDI-Public: (01)10801902029291(11)240320(17)280531(10)71F24C0758(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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 Model Number: IPN918561
• Device Catalogue Number: CV-15854
• Device Lot Number: 71F24C0758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2024
• 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