MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW EPIDURAL CATHETERIZATION KIT: 19 GA; ANESTHESIA CONDUCTION CATHETER

Catalog Number	AK-05501
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687)
Date of Event	06/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "nurse removed epidural catheter on (b)(6), unaware that part of the catheter was still in the patient.Fast forward a couple weeks later, with a couple instances of the patient calling in for back pain and she did have some paresthesias in her lower extremities.The patient needed a stat ct for imaging, to find out exactly what part was left inside, and then needed emergency laminectomy, foreign body removal.For the procedure, she needed general anesthesia, intubation, medications for the procedure itself, additional pain medication and then neurosurgical observation during her admission.Patient has recovered and is at home, after delivery and her emergency surgery.She's being followed up by obstetrics and neurosurgery.".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "nurse removed epidural catheter on 6/28, unaware that part of the catheter was still in the patient.Fast forward a couple weeks later, with a couple instances of the patient calling in for back pain and she did have some paresthesias in her lower extremities.The patient needed a stat ct for imaging, to find out exactly what part was left inside, and then needed emergency laminectomy, foreign body removal.For the procedure, she needed general anesthesia , intubation, medications for the procedure itself, additional pain medication and then neurosurgical observation during her admission.Patient has recovered and is at home, after delivery and her emergency surgery.She's being followed up by obstetrics and neurosurgery.".
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 KIT: 19 GA
• 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: 22793745
• Report Number: 9680794-2025-00675
• Device Sequence Number: 12959101
• Product Code: BSO
• UDI-Device Identifier: 40801902005128
• UDI-Public: (01)40801902005128(11)250513(17)260630(10)33F25A0617(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): 07/17/2025

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: 06/30/2026
• Device Catalogue Number: AK-05501
• Device Lot Number: 33F25A0617
• 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: 07/17/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown