MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGB MAC KIT: 2L 9 FR DISTAL; INTRODUCER, CATHETER

Catalog Number	ASK-21242-BSWH2
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported, "leaking at the insertion site only when flushing or infusing the proximal lumen (white lumen).Flushes free and clear, no resistance and aspiration.No similarities with staff or inserters.No increase in volume while leaking at the insertion site.".Additional information received on 02apr2026: "the catheter was indwelling for approximately 3-5 days.There was leaking from the insertion site.The multi access catheter (mac) was removed due to event.".There was no report of any patient injury or consequence.The patient's current condition was reported as "fine".
Event or Problem Description
It was reported, "leaking at the insertion site only when flushing or infusing the proximal lumen (white lumen).Flushes free and clear, no resistance and aspiration.No similarities with staff or inserters.No increase in volume while leaking at the insertion site.".Additional information received on 02apr2026: "the catheter was indwelling for approximately 3-5 days.There was leaking from the insertion site.The multi access catheter (mac) was removed due to event.".There was no report of any patient injury or consequence.The patient's current condition was reported as "fine".
Additional Manufacturer Narrative
(b)(4) the customer returned one, mac catheter for analysis.Signs of use in the form of biological material were observed.It was noted that the obturator was returned and locked over the mac hemostasis body.Visual analysis of the mac revealed bending and a slight kink along the body.No other defects or anomalies were observed.The hemostasis valve and mac were tested according to three different parameters per amrq-000038 rev 14: low pressure leak resistance test (amrq-000038 section 7.2.6): this states, "when tested as described in annex e of bs en iso 11070, using a test pressure of 38 - 42 kpa maintained for 30s, there shall be no leakage sufficient to form one or more falling drops of water." the mac distal extension line was attached to the leak tester.With the distal end of the mac occluded, the distal line was pressurized to 42kpa for 30seconds.No leaks were detected from the hemostasis valve, which indicates that the valves are functional and intact.High pressure leak resistance test (amrq-000038 section 7.2.5): this states, "when tested as described in annex d of bs en iso 11070 , using a test pressure of 300 - 320 kpa maintained for 30s, there shall be no leakage sufficient to form one or more falling drops of water".The mac proximal and distal extension lines were individually attached to the lab leak tester.With the distal end of the mac occluded and a lab inventory obturator over the hemostasis body, the lines were pressurized to 320kpa for 30seconds.No leaks were detected from any portion of the mac, which indicates that the sheath assembly is intact.The ifu provided with the kit informs the user, "hemostasis valve must be occluded at all times to reduce the risk of air embolism or hemorrhage.If catheter introduction is delayed, temporarily cover valve opening with sterile gloved finger until obturator is inserted.Use arrow obturator, either included with this product or sold separately, to occlude hemostasis valve assembly.This will ensure that leakage does not occur and inner seal is protected from contamination".The report of a leaking insertion site when flushing/infusing the proximal extension line was not confirmed.The returned mac met all relevant visual and functional requirements.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.

• Brand Name: ARROW AGB MAC KIT: 2L 9 FR DISTAL
• Common Device Name: INTRODUCER, CATHETER
• 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: 24954040
• Report Number: 9680794-2026-00307
• Device Sequence Number: 14771920
• Product Code: OFC
• UDI-Device Identifier: 10801902220339
• UDI-Public: (01)10801902220339(11)251218(17)270731(10)33F25K0094(21)
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K011761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: ASK-21242-BSWH2
• Device Lot Number: 33F25K0094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2025
• 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