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 Codes	Hematoma (1884); Pain (1994)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "in the maternity ward, when inserting the epidural catheter, the anaesthesia intern noticed that the catheter was kinked but he continued the insertion.When attempting to insert the catheter between the vertebrae, it would not pass because the catheter would not advance.The consequence was discomfort and a long procedure and hematoma for the patient post the procedure.".

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24952001
• Report Number: 3006425876-2026-00434
• Device Sequence Number: 17453397
• Product Code: BSO
• UDI-Device Identifier: 10801902197570
• UDI-Public: (01)10801902197570(11)260120(17)271231(10)71F26A0495(21)
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: 71F26A0495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Supplement Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2026
• 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: Female