MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 16 CM; CATHETER PERCUTANEOUS

Model Number	IPN918758
Medical Device Problem Codes	Difficult to Insert (1316); Dull, Blunt (2407)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that " it was difficult to insert the needle into patient's skin, as if it was not bevelled.Intervention performed by a senior doctor." the device was replaced.There was no patient consequences besides pain.There was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer provided six photos for analysis.No obvious defects or anomalies were observed on any section of the needle.The customer also returned one 18ga introducer needle for analysis.No obvious signs of use were observed.Visual and microscopic examination of the needle bevel did not reveal any defects or anomalies of any kind.Further analysis of the needle revealed cracking on the hub.The customer was contacted to confirm if they were aware of the cracking.They confirmed that they were not aware of the cracking.Therefore, the circumstances of the cracking cannot be verified.The needle bevel length measured 0.1273", which is within the specification limits of 0.120"-0.138" per the cannula product drawing.The cannula outer diameter measured 0.0500", which is within the specification limits of 0.0495"-0.0505" per the cannula product drawing.The cannula inner diameter at the distal and proximal ends measured 0.041", which is within the specification limits of 0.041"-0.043" per the cannula product drawing.The returned needle was inserted through lab inventory simulated skin.The needle inserted with no issue.Performed per ifu statement, "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate".The report of a defective needle tip was not confirmed through investigation of the returned sample.Visual, dimensional, and functi onal analysis of the needle bevel revealed no defects or anomalies; however, the circumstances during use of the device could not be evaluated.A device history record review did not reveal any relevant findings to suggest a manufacturing issue.Based on the customer report and the sample received, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that " it was difficult to insert the needle into patient's skin, as if it was not bevelled.Intervention performed by a senior doctor." the device was replaced.There was no patient consequences besides pain.There was no medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 16 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: 23244548
• Report Number: 3006425876-2025-00908
• Device Sequence Number: 21443067
• Product Code: DQY
• UDI-Device Identifier: 10801902105223
• UDI-Public: (01)10801902105223(11)250210(17)290831(10)71F25B0224(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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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: IPN918758
• Device Catalogue Number: CV-12703
• Device Lot Number: 71F25B0224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• 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