MAUDE Adverse Event Report: Arrow International LLC ARROW ARTERIAL CATH SET: 20 GA X 8CM; CATHETER PERCUTANEOUS

Catalog Number	SAC-00820-PBX
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that five arterial kits from lot number 71f26c0995 were opened for use during the same procedure.Upon opening, the spring wire guide (swg) contained within each kit was observed to be bent/kinked.The issue was identified prior to patient use, and none of the affected devices were used.There was no patient involvement associated with this event.No patient injury, adverse health consequences, or clinically significant harm were reported.Associated mdrs include 3006425876-2026-00820 (device #1), 3006425876-2026-00839 (device #2), 3006425876-2026-00840 (device #3), 3006425876-2026-00841 (device #4).
Additional Manufacturer Narrative
Qn#(b)(4).

• Brand Name: ARROW ARTERIAL CATH SET: 20 GA X 8CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: 50077255
• Report Number: 3006425876-2026-00838
• Device Sequence Number: 21518625
• Product Code: DQY
• UDI-Device Identifier: 10801902197327
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K093050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2026

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: SAC-00820-PBX
• Device Lot Number: 71F26C0995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2026
• 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.
• Patient Sex: Unknown