MAUDE Adverse Event Report: Arrow International LLC ARROW EPIDURAL CATHETERIZATION SET NRFIT; ANESTHESIA CONDUCTION CATHETER

Model Number	IPN920780
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2026
Type of Reportable Event	Malfunction

• Brand Name: ARROW EPIDURAL CATHETERIZATION SET NRFIT
• 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: 50144557
• Report Number: 3006425876-2026-00856
• Device Sequence Number: 18823973
• Product Code: BSO
• UDI-Device Identifier: 10801902197730
• UDI-Public: (01)10801902197730(11)260408(17)280331(10)71F26C1028
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2026

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: IPN920780
• Device Catalogue Number: OT19TKPSS
• Device Lot Number: 71F26C1028
• 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: 07/13/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/10/2026
• 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
• Patient Sex: Unknown