MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number	CDC-45703-XPN1A
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported" my infection control/vascular team director, just brought me a catheter and told me that when the physician went to flush one of the lumens the flush went back up into one of the other lumens instead of down the catheter." the catheter was removed and replaced.There was no patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4) the customer returned one 3-lumen catheter, needle holder, and 3 sodium chloride injections for evaluation.Visual inspection of the catheter revealed no obvious defects or anomalies.The needle holder was clamped to the distal end of the catheter body.Apart from that, the device appeared typical.The catheter body total length from juncture hub to the end of the distal tip measured at 215mm, which is within the specifications of 207mm - 227mm per product drawing.The outer diameter of the proximal extension line was 0.0855", which is within the specification limits of 0.084" -0.088" per proximal extension line extrusion drawing.The outer diameter of the distal extension line was 0.0852", which is within the specification limits of 0.084" -0.088" per distal extension line extrusion drawing.Functional inspection was performed per the product ifu which states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the catheter lumens were flushed with water using a lab inventory syringe.When flushing from the proximal lumen, some water was found exiting from the distal extension line.Similarly, when flushing from the distal extension line, water was found exiting from the proximal extension line.The flushing was repeated multiple times with the same results.No leaks, crossover, or blockages were observed with the medial extension line, which functioned as intended.The returned catheter was then tested per bs en iso 10555-1 section 8.7 (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.The catheter was connected to a lab leak tester and pressurized to 300 kpa for 30 seconds with the distal end occluded.The extension lines were connected to the leak tester, and when individually pressurized, crossover was detected from the distal and proximal extension lines.Based on the results of functional testing, the reported issue was repli cated and confirmed.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "ensure catheter patency prior to use.Do not use syringes smaller than 10 ml (a fluid filled 1 ml syringe can exceed 300 psi) to reduce risk of intraluminal leakage or catheter rupture." the customer report of catheter backflow was confirmed through complaint investigation of the returned sample.During functional testing, inter lumen crossover was observed between the proximal and distal lumens.The catheter met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.Based on the customer report and functional testing results, the probable root cause for this event is manufacturing related.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported" my infection control/vascular team director, just brought me a catheter and told me that when the physician went to flush one of the lumens the flush went back up into one of the other lumens instead of down the catheter." the catheter was removed and replaced.There was no patient harm or injury.The patient's current condition is reported as "fine".

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPE
• 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: 22095156
• Report Number: 9680794-2025-00433
• Device Sequence Number: 15182689
• Product Code: FOZ
• UDI-Device Identifier: 10801902162042
• UDI-Public: (01)10801902162042(11)250130(17)260228(10)33F24L0014(21)
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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: 02/28/2026
• Device Catalogue Number: CDC-45703-XPN1A
• Device Lot Number: 33F24L0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• 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