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

Model Number	IPN920760
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "needle bent during insertion: it happened with 3 units.Another kit was used successfully.There was no reported patient harm or consequence." associated complaints 3006425876-2026-00366, 3006425876-2026-00367.
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint of the needle was bent was confirmed based on the sample received.Visual examination of the returned sample revealed the needle appeared to be bent.The cannula was bent toward the center of the cannula.A device history record review was performed on the epidural needle with no relevant findings.It is unknown how the needle was handled prior to and during use and the pressure used for insertion and removal.Therefore, based on the information provided and the condition of the sample received, the potential cause of this complaint could not be determined.Further investigation has been initiated by the anesthesia research and deleopment team within the teleflex quality system to determine a probable cause.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "needle bent during insertion: it happened with 3 units.Another kit was used successfully.There was no reported patient harm or consequence." associated complaints 3006425876-2026-00366, 3006425876-2026-00367 and 3006425876-2026-00368.

• 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: 24763718
• Report Number: 3006425876-2026-00368
• Device Sequence Number: 21401765
• Product Code: BSO
• UDI-Device Identifier: 10801902197570
• UDI-Public: (01)10801902197570(11)250620(17)270531(10)71F25F0555(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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 71F25F0555
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2025
• 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