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

Model Number	IPN920769
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn #(b)(4).
Event or Problem Description
It was reported that, "after the insertion of the device for labor analgesia and the administration of 15 ml of local anesthetic, the filter became completely filled with blood despite all the aspiration checks and tests with the local anesthetic.The catheter is undoubtedly more rigid than the one used previously and slides with difficulty inside the needle, it creates friction, and this is felt above all during the needle removal procedure.The doctor says that due to its rigidity the catheter slips out when the introducer is removed.To prevent this, they push the catheter further in, risking the possibility of puncturing a blood vessel, which is particularly engorged in pregnant patients.A vessel has been damaged".
Event or Problem Description
It was reported that "after the insertion of the device for labor analgesia and the administration of 15 ml of local anesthetic, the filter became completely filled with blood despite all the aspiration checks and tests with the local anesthetic.The catheter is undoubtedly more rigid than the one used previously and slides with difficulty inside the needle, it creates friction, and this is felt above all during the needle removal procedure.The doctor says that due to its rigidity the catheter slips out when the introducer is removed.To prevent this, they push the catheter further in, risking the possibility of puncturing a blood vessel, which is particularly engorged in pregnant patients.A vessel has been damaged.".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW 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: 21695726
• Report Number: 3006425876-2025-00297
• Device Sequence Number: 21140863
• Product Code: BSO
• UDI-Device Identifier: 40801902062510
• UDI-Public: (01)40801902062510(11)240322(17)260228(10)71F24C0789(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: IPN920769
• Device Catalogue Number: JC-05400-DCS
• Device Lot Number: 71F24C0789
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2024
• 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: Female