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

Model Number	IPN920760
Medical Device Problem Codes	Material Twisted/Bent (2981); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "we have received feedback from our anaesthetists regarding the armoured epidural sets concerning the diameter of the needle, which slides too easily (smaller diameter?) and bends more easily.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The reported complaint of the needle was bent was confirmed based on the investigation of the sample received.The customer returned one epidural needle and lidstock.Visual examination of the returned sample revealed the needle appeared to be bent.The cannula was bent in multiple places throughout the cannula.The manufacturing site concluded, the damage to the needle could not be manufacturing/supplier related based on the damage occurring during use and after the stylet was removed.It is unknown how the needle was handled prior to and during use and the pressure used for insertion and removal.A device history record review was performed on the epidural needle with no relevant findings.Therefore, based on the information provided, the condition of the sample received, and manufacturing site's conclusion, the potential cause of this complaint could not be determined.No further action is required at this time.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "we have received feedback from our anaesthetists regarding the armoured epidural sets concerning the diameter of the needle, which slides too easily (smaller diameter?) and bends more easily.".

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23299094
• Report Number: 3006425876-2025-00958
• Device Sequence Number: 10192855
• Product Code: BSO
• UDI-Device Identifier: 40801902029674
• UDI-Public: (01)40801902029674(11)241219(17)261130(10)71F24M0679(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): 09/25/2025

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: 71F24M0679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• 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