MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC SET 2-LUMEN: 5 FR X 19-5/8IN (50 CM; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-05052-HP
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the white line of the line was blocked at the y-junction, preventing even the guide wire from passing through.This situation arose during the procedure, necessitating the insertion of another line".There was no patient harm or injury.The patient's current condition is reported as "discharged from the clinic".
Additional Manufacturer Narrative
(b)(4).The customer returned one opened picc kit including a 2-lumen catheter.No signs of use in the form of biological material were observed on the catheter.The catheter was returned severed around the 25 cm marking.The severed portion of the catheter was not returned.A blockage was observed in the proximal extension line at the juncture hub.The proximal line appeared to decrease in diameter in the same area.No other defects or abnormalities were observed.The catheter body measured 26.90 cm, which indicates between 23.42 cm and 23.90 cm of the catheter body was severed per the catheter product drawing.The outer diameter of the catheter body measured.0690", which is within the specification limits of.0660" - 0710" per the catheter body extrusion product drawing.The outer diameter of the proximal extension line measured.096", which is within the specification limits of.093" -.097" per the proximal extension line extrusion product drawing.A lab inventory syringe filled with water was attached to the proximal extension line and flushed.A complete blockage was met; therefore, the line did not flush as intended.The distal extension flushed as intended.Performed per ifu statement, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." a.018" diameter lab inventory guidewire was advanced into the proximal luer hub.A blockage was met at the juncture hub.The catheter was cross sectioned and revealed a blockage was completely obstructing the proximal lumen.A perpendicular cross section was made to remove the blockage.The blockage measured approximately.042" across.Removal of the blockage revealed a decrease in the diameter of the proximal extension line at the juncture hub.The lab inventory guidewire was reinserted into the proximal lumen.Despite the removal of the blockage, the guidewire could not pass due to the pinching of the proximal extension line.The blockage was sent to ftir testing and matched > 80% to poly (ethyl acrylate).A device history record review was performed and no relevant findings were identified.The report of a blocked extension line was confirmed by complaint investigation.Visual and functional analysis revealed a blockage in the proximal extension line.Cross sectioning and removal of the blockage revealed a decrease in the diameter of the proximal extension line.The blockage was sent to ftir testing and matched > 80% to poly (ethyl acrylate).Based on the customer report and the sample received , manufacturing likely cause or contributed to this issue.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "the white line of the line was blocked at the y-junction, preventing even the guide wire from passing through.This situation arose during the procedure, necessitating the insertion of another line".There was no patient harm or injury.The patient's current condition is reported as "discharged from the clinic".

• Brand Name: ARROW PICC SET 2-LUMEN: 5 FR X 19-5/8IN (50 CM
• Common Device Name: CATHETER, INTRAVASCULAR, THER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23876564
• Report Number: 9680794-2025-01055
• Device Sequence Number: 17310721
• Product Code: LJS
• UDI-Device Identifier: 10801902095388
• UDI-Public: (01)10801902095388(11)250423(17)270331(10)14F25C0155(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K042126
• 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): 11/28/2025

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: PR-05052-HP
• Device Lot Number: 14F25C0155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2025
• 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