MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC 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	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that " an incident occurred on (b)(6) 2026.The epidural needle bent significantly in the female patient's back.Apart from a longer procedure requiring two punctures, there were no consequences for the patient.The device was not kept, but photos are available in the attachment.".
Additional Manufacturer Narrative
(b)(4).It was reported that the epidural needle was bent.No sample was returned for evaluation; however, the customer provided photographs depicting a bent needle and an associated kit.Visual, dimensional, and functional inspections could not be performed due to the absence of a returned sample.Additional testing was also not conducted for this reason.A device history record (dhr) review was conducted, and no manufacturing or quality-related issues were identified.A review of the design history for the associated part number did not identify any material or design changes within the past two years that could be associated with the reported condition.Based on the available information, including the provided photographs, the reported issue could not be confirmed through physical evaluation.The root cause could not be determined due to the absence of a returned sample.No corrective or preventive actions were initiated, as the probable cause could not be established.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that " an incident occurred on (b)(6) 2026.The epidural needle bent significantly in the female patient's back.Apart from a longer procedure requiring two punctures, there were no consequences for the patient.The device was not kept, but photos are available in the attachment.".

• Brand Name: 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24543166
• Report Number: 3006425876-2026-00281
• Device Sequence Number: 13079369
• Product Code: BSO
• UDI-Device Identifier: 10801902197730
• UDI-Public: (01)10801902197730(11)251127(17)271031(10)71F25L0294(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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: 71F25L0294
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2025
• 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: Female