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

Catalog Number	AK-05502
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Foreign Body In Patient (2687)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "during removal of epidural catheter, the plastic portion was retained in the patient after attempting a removal.The rest of the catheter came out easily with no resistance.Part of the catheter is still inside the patient, around 5.5cm left.No existing symptoms as of now.Doctor thinks that the bevel edge of the hypodermic needle might have sheared the catheter." additional information: "patient was having breakthrough pain during labor analgesia, clinician decided to replace catheter during labor.They pulled the catheter, able to remove most of it, but the distal end (about 5 cm of the plastic portion) was remaining in the patient's body.There was no tugging when removing, no resistance, it was easy to remove." associated complaints 9680794-2025-00498.
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that: "during removal of epidural catheter, the plastic portion was retained in the patient after attempting a removal.The rest of the catheter came out easily with no resistance.Part of the catheter is still inside the patient, around 5.5cm left.No existing symptoms as of now.Doctor thinks that the bevel edge of the hypodermic needle might have sheared the catheter." additional information: "patient was having breakthrough pain during labor analgesia, clinician decided to replace catheter during labor.They pulled the catheter, able to remove most of it, but the distal end (about 5 cm of the plastic portion) was remaining in the patient's body.There was no tugging when removing, no resistance, it was easy to remove." associated complaints 9680794-2025-00499 and 9680794-2025-00498.
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.The customer did provide photos that appear to show a separated epidural catheter.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 KIT
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22282169
• Report Number: 9680794-2025-00499
• Device Sequence Number: 8875571
• Product Code: BSO
• UDI-Device Identifier: 60801902005139
• UDI-Public: (01)60801902005139(11)250129(17)260430(10)33F24L0630(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 05/27/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: AK-05502
• Device Lot Number: 33F24L0630
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2025
• 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