MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 4FR X 8CM; CATHETER, PERCUTANEOUS

Model Number	IPN918480
Medical Device Problem Codes	Difficult to Advance (2920); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Needle Stick/Puncture (2462)
Date of Event	09/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "on (b)(6) 2025, in paediatric intensive care, during the insertion of a central venous catheter, the guide did not advance properly and it became stuck.When the guide was removed, it looked twisted and bent.The catheter could not be inserted.The incident caused slight bleeding at the puncture site.A second catheter was inserted, requiring a second puncture." there was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned a single guidewire advanced partially through a needle and introducer for evaluation.Signs of use were observed in the form of excess biological material.Visual analysis revealed multiple kinks across the guidewire.Microscopic examination confirmed the damage and revealed that the distal j-bend was misshapen due to the severity of the kinking.Microscopic examination also revealed that the distal and proximal welds were observed to be full and spherical.Visual analysis did not detect any abnormalities in the needle.The major kinks on the guidewire measured 5mm-30mm and 215mm from the distal weld.The guidewire total length measured 454.0 mm, which is within the specification limits of 449.2mm-458.8mm per the guide wire product drawing.The guide wire outer diameter measured 0.440mm, which is within the specification limits of 0.432m-0.457mm per the guide wire product drawing.The needle cannula inner diameter at the distal and proximal ends measured 0.0230", which is within the specification limits of 0.0225"-0.0240" per the cannula product drawing.The needle cannula outer diameter measured 0.0325", which is within the specification limits of 0.0320"-0.0325" per the cannula product drawing.The guidewire was passed through the returned needle.Resistance was encountered at the location of the kinking; however, all functional sections of the guide wire passed with no resistance.Performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished , radiographic visualization should be obtained and further consultation requested." the report of a kinked guidewire was confirmed through analysis of the returned sample.Visual analysis revealed multiple kinks along the body of the guidewire.Despite the damage, the guidewire met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report that the damage was observed during use and the sample received, unintentional use error likely caused or contributed to the reported event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "on (b)(6) 2025, in paediatric intensive care, during the insertion of a central venous catheter, the guide did not advance properly and it became stuck.When the guide was removed, it looked twisted and bent.The catheter could not be inserted.The incident caused slight bleeding at the puncture site.A second catheter was inserted, requiring a second puncture." there was no medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC SET: 3-LUMEN 4FR X 8CM
• 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: 23401922
• Report Number: 3006425876-2025-01001
• Device Sequence Number: 9945667
• Product Code: DQY
• UDI-Device Identifier: 10801902027464
• UDI-Public: (01)10801902027464(11)240226(17)281231(10)71F24J0957(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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2025

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: IPN918480
• Device Catalogue Number: CS-15403
• Device Lot Number: 71F24J0957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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