MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 5 FR X 8 IN; CATHETER PERCUTANEOUS

Catalog Number	CS-04301-EJ
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the extension line was found cracked during placement of the catheter.Therefore, the catheter was removed and replaced with a new one.No harm to the patient occurred." there was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one 1-lumen catheter for analysis.Signs of use , including biological material, were observed within the extension line near the luer hub.Visual analysis revealed a linear, sharp cut on the distal extension line near the luer 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 cut in the distal extension line was located 3 mm from the luer hub.The outer diameter of the distal extension line measured 2.16mm, which is within the specification limits of 2.13mm - 2.21mm per the distal extension line extrusion product drawing.The inner diameter of the distal extension line measured 1.4478mm, which is within the specification limits of 1.42mm-1.50mm per the distal extension line extrusion product drawing.The returned catheter was functionally tested per the ifu provided with this kit.The instructions state, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." a laboratory inventory syringe filled with water was attached to the distal extension line and flushed.When flushing the distal extension line, a definite leak was observed from the crack.A manual tug test confirmed that the extension line was secure within its lumen.Based on input from manufacturing and r & d, the observed extension line damage appears more consistent with a clean cut from a sharp object than with the crack or rupture patterns.Manufacturing indicated that no sharp tools or objects are used during the catheter manufacturing process, and r & d noted that, if this damage had occurred during production, it likely would have been detected during 100% leak testing.Based on these considerations, both groups indicated that the damage is not believed to be manufacturing-related and is more likely associated with sharp-object interaction during the procedure.A device history record review was performed, and no relevant findings were identified.The ifu provided with the 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 customer-reported extension line leak was confirmed through investigation of the returned sample.Visual and functional evaluation identified a linear slit-like cut in the distal extension line near the luer hub.Dimensional inspection confirmed that the cut was located 3 mm from the luer hub.Microscopic examination showed that the edges of the cut were smooth and appeared consistent with damage resulting from contact with a sharp instrument.Based on input from manufacturing and r & d, the observed extension line damage appears more consistent with a clean cut from a sharp object.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 "the extension line was found cracked during placement of the catheter.Therefore, the catheter was removed and replaced with a new one.No harm to the patient occurred." there was no medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC SET: 5 FR X 8 IN
• 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: 24871902
• Report Number: 3006425876-2026-00421
• Device Sequence Number: 10019652
• Product Code: DQY
• UDI-Device Identifier: 00801902104595
• UDI-Public: (01)00801902104595(11)240515(17)290430(10)71F24E0206(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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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
• Device Catalogue Number: CS-04301-EJ
• Device Lot Number: 71F24E0206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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