MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 8 FR X 20 CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CS-25802-E
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "an unknown white foreign object was found inside the tubing at the tip end of the cvc set.Due to surgical needs, the cvc was inserted in the operating room on june 10.On june 11, an x-ray revealed a clear radiopaque area at the tip end of the cvc.After confirmation by the physician, it was verified that this was not a retained guidewire.On june 12, the cvc was removed from the patient, and a further x-ray confirmed a distinct radiopaque segment at the tip end.Upon cutting open the tubing, an unknown white foreign object was found inside one of the lumens." the user changed to a new set.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned six photos for analysis.One photo showed the lidstock, two photos showed the cross-sectioned catheter body, and three photos showed x-ray images of the catheter body.The photos showing the cross-section clearly show a white substance in the proximal lumen.The material appears to resemble the plug extrusion and is part of the catheter design.This plug is also visible under x-ray to assist with catheter tip placement.The customer also returned one, 2-lumen cvc catheter.Signs of use in the form of biological material were observed on the sample.It was noted that the catheter body was returned severed, which matches the sample shown in the customer images.Visual analysis on the returned sample did not reveal any obvious defects or anomalies of any kind.Microscopic examination of the proximal skive hole confirmed that the plug extrusion was present as intended.A device history record reviews were performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "catheter tip location should be confirmed according to institutional policy and procedure".The report of a foreign, white material inside the catheter was not confirmed through complaint investigation.Per the returned sample and the customer photos, the white substance inside the proximal skive hole is actually the plug extrusion and is intended for the catheter design.Therefore, based on the customer report and the sample received, no problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "an unknown white foreign object was found inside the tubing at the tip end of the cvc set.Due to surgical needs, the cvc was inserted in the operating room on (b)(6).On (b)(6), an x-ray revealed a clear radiopaque area at the tip end of the cvc.After confirmation by the physician, it was verified that this was not a retained guidewire.On june 12, the cvc was removed from the patient, and a further x-ray confirmed a distinct radiopaque segment at the tip end.Upon cutting open the tubing, an unknown white foreign object was found inside one of the lumens." the user changed to a new set.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: 2-LUMEN 8 FR X 20 CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 22436533
• Report Number: 3006425876-2025-00613
• Device Sequence Number: 3163992
• Product Code: FOZ
• UDI-Device Identifier: 00801902102331
• UDI-Public: (01)00801902102331(11)240528(17)260430(10)71F24E1022(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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 Expiration Date: 04/30/2026
• Device Catalogue Number: CS-25802-E
• Device Lot Number: 71F24E1022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• 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