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

Model Number	IPN920780
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Event description: "incident occurred on (b)(6) 2026.The low-pressure syringe leaked at the level of the plunger.Patient had a puncture of the dural.Blood patch was needed to treat.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4) the reported complaint of the patient having a puncture of the "dural" could not be confirmed based on the sample received.The actual complaint sample was not returned; only a representative sample was received.The ifu for this product warns the user to remove the needle and attempt a new puncture if blood or spinal fluid is returned in the plunger barrel.A device history record review was performed on the epidural needle with no relevant findings.Based on this, the complaint could not be confirmed based upon the information provided and without the actual complaint sample.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
Event description: "incident occurred on (b)(6) 2026.The low-pressure syringe leaked at the level of the plunger.Patient had a puncture of the dural.Blood patch was needed to treat.".

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24504943
• Report Number: 3006425876-2026-00264
• Device Sequence Number: 10509911
• Product Code: BSO
• UDI-Device Identifier: 10801902197730
• UDI-Public: (01)10801902197730(11)251112(17)271031(10)71F25L0116(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): 02/10/2026

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: IPN920780
• Device Catalogue Number: OT19TKPSS
• Device Lot Number: 71F25L0116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2025
• 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