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

Model Number	IPN920769
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "on (b)(6) 2026, when the needle was in position, the catheter could not be inserted, needle bent.A catheter from another epidural kit of a different brand, which was more rigid, was used and inserted successfully.When we removed the needle we observed it was bent.Consequence for the patient: multiple punctures.No other harm or health consequences.".
Additional Manufacturer Narrative
(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's tip appeared to be bent.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.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "on (b)(6) 2026, when the needle was in position, the catheter could not be inserted, needle bent.A catheter from another epidural kit of a different brand, which was more rigid, was used and inserted successfully.When we removed the needle, we observed it was bent.Consequence for the patient: multiple punctures.No other harm or health consequences.".

• 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: 24764910
• Report Number: 3006425876-2026-00365
• Device Sequence Number: 10268843
• 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): 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: IPN920769
• Device Catalogue Number: JC-05400-DCS
• Device Lot Number: 71F25M0490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2026
• 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: 04/09/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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