MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION CATHETER

Model Number	IPN920760
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction

• Brand Name: ARROW EPIDURAL CATHETERIZATION SET
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• 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: edel connelly ; ida business and technology park, dublin rd; athlone 27560 ; EI 27560
• MDR Report Key: 25905455
• Report Number: 3006425876-2026-00797
• Device Sequence Number: 8476554
• Product Code: BSO
• UDI-Device Identifier: 10801902197570
• UDI-Public: (01)10801902197570(11)260312(17)280229(10)71F26C0191
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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 Model Number: IPN920760
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F26C0191
• Date Returned to Manufacturer: 07/20/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Supplement Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 07/22/2026
• Supplement Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2026
• 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
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 143 LB