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

Catalog Number	SJ-05501
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "rn contacted crna stating they were having difficulty removing the patient's epidural catheter.The catheter had been untapped; crna pulled on the tape/catheter and the catheter appeared to come out without significant difficulty and appeared to be intact.Afterwards, crna contacted their ob colleagues and discussed the case and decided the prudent course of action would be to simply obtain an ap and lateral lumber spine x-ray due to difficult epidural catheter removal.They were notified at 22:47 hours on (b)(6) 2025 that the x'ray was clear and the patient was doing fine, with no complications voiced.Again, notified at 16:40 hours on (b)(6) by (b)(6), crna that the x-ray had been read again and was found to be clear then read for a 3rd time and a portion of the epidural catheter was identified.The patient was contacted and requested to return to the hospital for ed evaluation.The patient returned and a ct was obtained.Results of ct spine lumbar with iv contrast: there is a fragment of an epidural catheter that courses just inferior and lateral to the l3 spinous process.This catheter enters the spinal canal and makes several loops in the epidural space along the posterolateral aspect of the thecal sac to the left of the midline with the tip just extending into the origin of the left l3-l4 neural foramen.The tip of the catheter lies caudal to the traversing l3 nerve root and does not contact the l3 nerve root.Approximately 6 cm of epidural catheter broke during removal and retained in spine.Crna also mentioned difficulty with threading the catheter because it feels "too flimsy" and needed to switch to a competitor in the stock room, which thread with no issues.".
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.
Event or Problem Description
It was reported that: "rn contacted crna stating they were having difficulty removing the patient's epidural catheter.The catheter had been untapped; crna pulled on the tape/catheter and the catheter appeared to come out without significant difficulty and appeared to be intact.Afterwards, crna contacted their ob colleagues and discussed the case and decided the prudent course of action would be to simply obtain an ap and lateral lumber spine x-ray due to difficult epidural catheter removal.They were notified at 22:47 hours on (b)(6) 2025 that the x'ray was clear and the patient was doing fine, with no complications voiced.Again, notified at 16:40 hours on (b)(6) by (b)(6) crna that the x-ray had been read again and was found to be clear then read for a 3rd time and a portion of the epidural catheter was identified.The patient was contacted and requested to return to the hospital for ed evaluation.The patient returned and a ct was obtained.Results of ct spine lumbar with iv contrast: there is a fragment of an epidural catheter that courses just inferior and lateral to the l3 spinous process.This catheter enters the spinal canal and makes several loops in the epidural space along the posterolateral aspect of the thecal sac to the left of the midline with the tip just extending into the origin of the left l3-l4 neural foramen.The tip of the catheter lies caudal to the traversing l3 nerve root and does not contact the l3 nerve root.Approximately 6 cm of epidural catheter broke during removal and retained in spine.Crna also mentioned difficulty with threading the catheter because it feels "too flimsy" and needed to switch to a competitor in the stock room, which thread with no issues.".

• 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: 23836286
• Report Number: 9680794-2025-01046
• Device Sequence Number: 5068409
• Product Code: BSO
• UDI-Device Identifier: 50801902013694
• UDI-Public: (01)50801902013694(11)250719(17)260630(10)33F25E0295(21)
• Combination Product (Y/N): N
• 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): 11/24/2025

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: 06/30/2026
• Device Catalogue Number: SJ-05501
• Device Lot Number: 33F25E0295
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2025
• 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