MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Model Number	IPN918726
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "while using the device to infuse norepinephrine via the proximal line, it was observed that the side eyes along the catheter became blocked due to the formation of blood clots.This prevented the administration of norepinephrine".Additional information reports, "to solve the problem, we first swapped the noradrenaline on the distal line, then changed the catheter in a second step.The 2nd kit was inserted with no problem".Associated mdr number 3006425876-2024-00169.
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one 4-l cvc for analysis.Signs of use were observed on the catheter body and inside the extension lines.Visual inspection of the catheter revealed no obvious defects or anomalies.The catheter body length measured 167mm, which is within the specifications of 157-177mm per product drawing.The proximal extension line outer diameter measured 2.19mm which is within the specifications of 2.13-2.21mm per product drawing.The proximal extension line inner diameter measured 1.4478mm, which is within the specifications of 1.42-1.50mm per product drawing.This indicates that the wall thickness measured within specifications.Functional inspection of the catheter was performed per the instructions for use (ifu) provided with the kit which states , "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." a lab inventory 10ml syringe was used to flush all catheter lumens.Water was observed exiting the appropriate skive hole for all extension lines.No leaks or blockages were observed anywhere on the catheter body.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with the kit warns the user, "check lumen patency by attaching a syringe to each extension line and aspirate until free flow of venous blood is observed." the customer report of a blocked catheter could not be confirmed through complaint investigation of the returned sample.Visual inspection revealed no defects or anomalies.The returned catheter met all relevant dimensional and functional requirements, with no blockages found in the catheter during lab testing.A device history record review was performed with no relevant findings.Based on these circumstances, no problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "while using the device to infuse norepinephrine via the proximal line, it was observed that the side eyes along the catheter became blocked due to the formation of blood clots.This prevented the administration of norepinephrine".Additional information reports, "to solve the problem, we first swapped the noradrenaline on the distal line, then changed the catheter in a second step.The 2nd kit was inserted with no problem".Associated mdr number 3006425876-2024-00169.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
• 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: 18767775
• Report Number: 3006425876-2024-00170
• Device Sequence Number: 12739376
• Product Code: DQY
• UDI-Device Identifier: 10801902029239
• UDI-Public: 10801902029239
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

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 Model Number: IPN918726
• Device Catalogue Number: CV-12854
• Device Lot Number: 71F23C1189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2022
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown