MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 1-LUMEN 5 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	AK-04301-J
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the catheter was suspected to be leaking during placement.Therefore, it was removed and replaced with a new one.No injury to the patient occurred." 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 single-lumen catheter.Signs of use in the form of biological material were observed on the returned catheter.A catheter clamp and fastener were attached towards the proximal end of the catheter body.Visual analysis revealed a hole between the catheter clamp and the juncture hub.Microscopic analysis confirmed the damage, and the edges of the hole appeared smooth and uniform which is consistent with contact with a sharp instrument (i.E.Scissors, scalpel, needle bevel, etc).The hole in the catheter measured 19 mm from the juncture hub.The catheter body length measured 207 mm, which is not within the specification limits of 201.5 mm - 210.5 per catheter product drawing.The catheter outer diameter measured 1.67 mm, which is within the specification limits of 1.65 mm - 1.75 mm per catheter extrusion product drawing.The catheter was 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)." the lumen was flushed using a lab inventory syringe filled with water.A leak was observed at the hole.A device history record review was performed, 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 a catheter leak was confirmed through complaint investigation of the returned sample.Visual inspection revealed a hole towards the proximal end of the catheter body.The edges of the hole were smooth and appeared consistent with contact with a sharp instrument (i.E.Scalpel, scissors, needle bevel , etc.).Functional testing revealed a leak through the hole when flushing the lumen.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 "the catheter was suspected to be leaking during placement.Therefore, it was removed and replaced with a new one.No injury to the patient occurred." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC KIT: 1-LUMEN 5 FR X 20 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: 23393072
• Report Number: 3006425876-2025-01000
• Device Sequence Number: 13274951
• Product Code: DQY
• UDI-Device Identifier: 00801902101914
• UDI-Public: (01)00801902101914(11)240207(17)261231(10)71F24A1464(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2025

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
• Device Catalogue Number: AK-04301-J
• Device Lot Number: 71F24A1464
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• 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