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

Model Number	IPN920769
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "tuohy needle grip: the wings are smaller than expected and do not ensure a secure and stable grip during handling." no patient harm or injury reported.The patient's status is reported as "fine.".
Additional Manufacturer Narrative
(b)(4).

• 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 25756670
• Report Number: 3006425876-2026-00753
• Device Sequence Number: 9669424
• Product Code: BSO
• UDI-Device Identifier: 10801902197631
• UDI-Public: (01)10801902197631(11)251205(17)271130(10)71F25M0156
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K140110
• 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): 06/11/2026

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: IPN920769
• Device Catalogue Number: JC-05400-DCS
• Device Lot Number: 71F25M0156
• Was Device Available for Evaluation?: No
• 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: 06/11/2026
• Supplement Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 07/08/2026
• Supplement Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2025
• 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: NONE REPORTED.
• Patient Sex: Unknown