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

Model Number	IPN920769
Medical Device Problem Codes	Use of Device Problem (1670); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "no sensation of passing through the ligaments and needles that bend easily.It difficult to know which structures we are passing through and therefore to administer epidurals safely.There were several punctures made on the same patient and the epidural had no effect during delivery.Another device was needded to complete procedure.".
Additional Manufacturer Narrative
(b)(4).The reported complaint of the needle bending could not be confirmed based on the sample received.The actual complaint sample was not returned; only a representative sample was received.The returned needle was visually examined with no visual issues found.A device history record review was performed on the epidural kit and epidural needle with no relevant findings.Therefore, based on this, the potential cause of this complaint could not be determined based upon the information provided and without the actual sample.It should be noted, the customer's issue of two kits with the same material # (jc-05400-dcs) having a different epidural needle for each kit was due to a material change of the epidural needle for the bill of material in nov-2025.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "no sensation of passing through the ligaments and needles that bend easily.It difficult to know which structures we are passing through and therefore to administer epidurals safely.There were several punctures made on the same patient and the epidural had no effect during delivery.Another device was needded to complete procedure.".

• Brand Name: 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24588797
• Report Number: 3006425876-2026-00297
• Device Sequence Number: 15823890
• Product Code: BSO
• UDI-Device Identifier: 10801902197631
• UDI-Public: (01)10801902197631(11)251212(17)271130(10)71F25M0490(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): 02/20/2026

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: 71F25M0490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2025
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown