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	Obstruction of Flow (2423); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "an incident has occurred on (b)(6) 2025.Involving the cvc used for the administration of unfractionated heparin (ufh) by electric syringe pump.This tubing of the cvc is very thin and easily twisted, which has led to several blockages of the electric syringe pump.These blockages have caused interruptions in the administration of unfractionated heparin to the patient.The "occlusion" alarm of the electric syringe pump was triggered on (b)(6) 2025, at around 11 a.M.It was not possible to determine how long the tubing had been twisted.The patient has been on unfractionated heparin since admission to the ward as part of treatment for a left intraventricular thrombus requiring strong anticoagulation." there was partial interruption of unfractioned heparin due to the obstructions related to the twisting of the catheter.The user replaced the central line, tubing, and dressing.There was no direct consequences related to the event.The patient's current condition was reported as "precarious but this is related to the underlying condition.".
Additional Manufacturer Narrative
(b)(4).The customer provided one image for analysis.The report of kinked extension lines was confirmed by the image, which shows that the distal, medial, and proximal extension lines kinked while in use on a patient.The extension lines appear to be twisted/folded under the catheter dressing in the customer image.The customer also returned a representative sample of a different lot number: (71f25f0069).The kit was unopened and contained all of its respective components.No defects were observed with the catheter inside the returned representative sample.The returned representative sample catheter was used for dimensional testing.The outer diameter of the distal extension line catheter measured 2.17mm, which is within the specification limits of 2.13mm - 2.21mm per the distal extension line extrusion product drawing.The outer diameter of the proximal extension line catheter measured 2.16mm , which is within the specification limits of 2.13mm - 2.21mm per the proximal extension line extrusion product drawing.The outer diameter of the medial extension line catheter measured 2.17mm, which is within the specification limits of 2.13mm - 2.21mm per the medial extension line extrusion product drawing.The returned representative sample catheter was used for functional testing.The instructions for use (ifu) provided with this kit were used to functionally test the sample.The ifu states , "check lumen patency by attaching a syringe to each extension line and aspirate until free flow of venous blood is observed.Flush lumen(s) to completely clear blood from catheter." all three lumens were successfully flushed using a lab inventory syringe with no issue.A device history record review was performed for both the reported lot and the representative kit lot, and no relevant findings were identified.The ifu provided with this kit warns 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 customer report of twisted extension lines was confirmed by visual inspection of the customer-supplied photo.The image shows a catheter in use with a patient with twisted/folded extension lines under the catheter dressing.However, full complaint verification testing could not be performed as the reported sample was not returned for analysis.A representative sample of a different batch: (71f25f0069) was returned instead.No defects were observed with the returned sample.Additionally, the returned sample passed all relevant dimensional and functional requirements.A device history record review was performed on both batches, and no relevant findings were identified.Without the actual 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 "an incident has occurred on (b)(6) 2025.Involving the cvc used for the administration of unfractionated heparin (ufh) by electric syringe pump.This tubing of the cvc is very thin and easily twisted, which has led to several blockages of the electric syringe pump.These blockages have caused interruptions in the administration of unfractionated heparin to the patient.The "occlusion" alarm of the electric syringe pump was triggered on (b)(6) 2025, at around 11 a.M.It was not possible to determine how long the tubing had been twisted.The patient has been on unfractionated heparin since admission to the ward as part of treatment for a left intraventricular thrombus requiring strong anticoagulation." there was partial interruption of unfractioned heparin due to the obstructions related to the twisting of the catheter.The user replaced the central line, tubing, and dressing.There was no direct consequences related to the event.The patient's current condition was reported as "precarious but this is related to the underlying condition.".

• 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: 23347431
• Report Number: 3006425876-2025-00961
• Device Sequence Number: 12714748
• Product Code: DQY
• UDI-Device Identifier: 10801902105223
• UDI-Public: (01)10801902105223(11)250415(17)290930(10)71F25D0308(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): 09/25/2025

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: 71F25D0308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• 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