MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number	CDC-21242-XCN1A
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "mac inserted and used in cvor surgery then patient transported to cvicu.Cvicu reported clot in distal (brown) lumen within 30 minutes of arrival and cannot aspirate through white proximal lumen".Additional information received states that there was no patient harm or injury.A new catheter was not inserted.The patient status is reported as "fine'.
Event or Problem Description
It was reported that "mac inserted and used in cvor surgery then patient transported to cvicu.Cvicu reported clot in distal (brown) lumen within 30 minutes of arrival and cannot aspirate through white proximal lumen".Additional information received states that there was no patient harm or injury.A new catheter was not inserted.The patient status is reported as "fine'.
Additional Manufacturer Narrative
(b)(4).The report of a multi-access catheter (mac) obstructed by a clot could not be confirmed through analysis of the returned sample.The customer returned one mac and lidstock for analysis.Signs-of-use in the form of biological material were observed on the mac.Visual, dimensional, and functional analysis of the returned sample did not reveal any evidence of a clot or damage resulting in an obstruction of the lumens.A device history record review did not reveal any relevant findings.The customer reported the use of a single-lumen infusion catheter (slic) as a companion to the returned device.Although the slic material is unknown, the teleflex slic component is labelled and cleared for use with psi sheaths only.The mac central venous catheter (cvc) companion component is intended for use with the mac as it allows appropriate luer care to reduce the risk of catheter occlusion.Use of a slic in conjunction with the mac could result in an increased risk of catheter occlusions.Based on these circumstances, unintentional use error likely caused or contributed to the reported event; however, the root caused cannot be determined as the clinical conditions at the time of the event cannot be confirmed.Patient conditions, catheter maintenance, medication, and indwell time can contribute to clots forming during use.Additionally, the ifu provided with the kit informs the user, "flush and connect distal side port to appropriate line as necessary.Confirm and monitor proximal port by aspirating until free flow of venous blood is observed.Connect all extension lines to appropriate luer lock line(s) as required.Unused port(s) may be 'locked' through injection cap(s) using standard hospital protocol.Clamps are provided on extension lines to occlude flow through each lumen during line and injection cap changes".The ifu also states, "to reduce the risk of damage to extension lines from excessive pressure, each clamp must be opened prior to infusing through that lumen".The ifu also states, "clinicians must be aware of complications/undesirable side effects associated with this device".Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a corrected data: n/a.

• Brand Name: ARROW MAC KIT: 2-L 9 FR DISTAL X 11.5 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 23596344
• Report Number: 9680794-2025-00962
• Device Sequence Number: 21154823
• Product Code: DYB
• UDI-Device Identifier: 10801902179286
• UDI-Public: (01)10801902179286(11)250709(17)270228(10)33F25D0707(21)
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K011761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: CDC-21242-XCN1A
• Device Lot Number: 33F25D0707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2025
• 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
• Patient Sex: Unknown