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	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that " on (b)(6) 2026, after insertion of the central venous line, we noticed that the dressing was very wet.(date of cvc insertion: (b)(6) 2026; date of cvc removal: (b)(6) 2026).When changing the dressing, we saw that the white line had a hole in it." the device was removed and replaced.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one 3-lumen cvc for analysis.Signs of use in the form of biological material were observed inside the proximal extension line near the juncture hub.Visual analysis revealed a linear slit-like cut on the proximal extension line near the juncture hub.Microscopic examination confirmed the damage , showing sharp edges with raised material deformation consistent with contact from a sharp metallic object (e.G., scalpel, needle bevel, or scissors).The proximal extension line outer diameter measured 2.19mm, which is within the specification limits of 2.13mm -2.21mm per proximal extension line extrusion product drawing.The proximal extension line inner diameter measured 1.4478mm, which is within the specification limits of 1.42mm - 1.50mm per proximal extension line extrusion product drawing.A lab inventory syringe filled with water was attached to each extension line.The distal and medial extension lines flushed as intended.Leaking was observed from a hole in the proximal extension line when it was flushed.The returned catheter was then tested per bs en iso 10555-1 section 4.7.1 (amrq-000071 rev15), which states that there shall be no liquid leakage in the form of one or more falling drops when pressurized to 300 kpa for 30 seconds.All three extension lines were individually connected to lab leak tester and pressurized to 300 kpa for 30 seconds.Leaking was observed from proximal extension line, remaining extension lines passed without leak.A manual tug test confirmed all lumens were secured to their respective hubs.A device history record review was performed, and no relevant findings were identified.The ifu provided with these kits 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 an extension line leak was confirmed through investigation of the returned sample.Functional and visual inspection revealed a linear slit-like cut on the proximal extension line near the juncture hub.The cut on the proximal extension line 6mm from the juncture hub.The edges of the cut were smooth and appeared consistent with damage resulting from contact with a sharp instrument (i.E.Scalpel , scissors, etc.).The catheter met all relevant dimensional requirements.A device history record review was performed, and no relevant findings were identified.Based on these circumstances , unintentional use error (contact with sharps) likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that " on (b)(6) 2026, after insertion of the central venous line, we noticed that the dressing was very wet.(date of cvc insertion: (b)(6) 2026; date of cvc removal: (b)(6) 2026).When changing the dressing, we saw that the white line had a hole in it." the device was removed and replaced.There was no patient harm or injury.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: 24343847
• Report Number: 3006425876-2026-00179
• Device Sequence Number: 21291165
• Product Code: DQY
• UDI-Device Identifier: 10801902183634
• UDI-Public: (01)10801902183634(11)250602(17)290930(10)71F25E1103(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): 01/21/2026

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: 71F25E1103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2025
• 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