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 Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	09/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "incident occurred on (b)(6) 2025.The cvc 3-lumen plastic tubing are very flexible and thin, which can cause twisting or kinking.(between the patient's and the first hub connection).The patient was on iv cordarone with an electric syringe pump, which led to occlusion of the electric syringe pump and interruption of the intravenous treatment.Patient was in atrial fibrillation at 150bpm." a bolus of iv cordarone was delivered to the patient.The patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
(b)(4).The customer returned an unopened, representative kit for analysis.The kit was opened to analyze the contents within.No defects or anomalies were observed on the catheter.Visual analysis could not be performed on the reported device without it being returned for analysis.The outer diameter of the medial extension line measured 2.14 mm which is within the specification limits of 2.13-2.21 mm per the medial extension line extrusion drawing.The inner diameter of the medial extension line measured 1.45 mm, which is within the specification limits of 1.42-1.50 mm per the medial extension line extrusion drawing.The outer diameter of the distal extension line measured 2.18 mm which is within the specification limits of 2.13-2.21 mm per the distal extension line extrusion drawing.The inner diameter of the distal extension line measured 1.45 mm, which is within the specification limits of 1.42-1.50 mm per the distal extension line extrusion drawing.The outer diameter of the proximal extension line measured 2.16 mm which is within the specification limits of 2.13-2.21 mm per the proximal extension line extrusion drawing.The inner diameter of the proximal extension line measured 1.45 mm, which is within the specification limits of 1.42-1.50 mm per the proximal extension line extrusion drawing.Dimensional analysis could not be performed on the reported device without it being returned for analysis.The catheter lumens were functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." each lumen was flushed using a lab inventory syringe filled with water and each lumen flush as intended without any leakages or blockages observed.Functional analysis could not be performed on the reported device without it being returned for analysis.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit informs the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the complaint of a kinked extension line was not confirmed by complaint investigation of the returned sample.A representative sample was returned and it met all relevant visual, dimensional, and functional requirements.Full complaint verification testing could not be performed as the reported device was not returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the reported 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 that "incident occurred on (b)(6) 2025.The cvc 3-lumen plastic tubing are very flexible and thin, which can cause twisting or kinking.(between the patient's and the first hub connection).The patient was on iv cordarone with an electric syringe pump, which led to occlusion of the electric syringe pump and interruption of the intravenous treatment.Patient was in atrial fibrillation at 150bpm." a bolus of iv cordarone was delivered to the patient.The patient's current condition is reported as "unknown".

• 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: 23257726
• Report Number: 3006425876-2025-00921
• Device Sequence Number: 15632914
• Product Code: DQY
• UDI-Device Identifier: 10801902105223
• UDI-Public: (01)10801902105223(11)250210(17)290831(10)71F25B0095(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): 09/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN918758
• Device Catalogue Number: CV-12703
• Device Lot Number: 71F25B0095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 10/27/2025
• 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