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

Catalog Number	WJ-05401
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "during attempted removal of an epidural catheter, the primary rn encountered resistance on the initial pull.The patient was repositioned and a second removal attempt was made, again meeting resistance.A second rn assisted, and additional attempts were made with patient repositioning, but resistance persisted.Anesthesia was consulted to assist with catheter removal.Upon evaluation, anesthesia also encountered resistance despite repositioning.Additional traction was applied during removal, at which time the catheter fractured, resulting in retention of a portion of the catheter.Subsequent imaging demonstrated a retained epidural catheter fragment near the superior margin of the l3 spinous process, slightly left of midline, entirely within the paraspinal soft tissue.After consultation with neurosurgery, the decision was made to manage the patient conservatively with observation and follow-up in two months.The patient was discharged home without surgical removal of the retained catheter fragment".
Additional Manufacturer Narrative
Qn# (b)(4).The reported complaint of the catheter breaking during removal was confirmed based upon the investigation of the sample received.The customer returned one catheter adapter and one epidural catheter piece.The returned components were received connected.The returned catheter piece showed signs of stretching as the extrusion and coil wire were stretched at the likely most distal end.The ifu for this product warns the user not to apply additional tension if the catheter begins to stretch as there is a risk for separation.A device history record review was performed on the epidural catheter with no relevant findings.Therefore, based upon the condition of the sample received and the observed evidence of the extrusion and coil wire stretching at the distal end, unintentional user error caused or contributed to this event.
Event or Problem Description
It was reported that "during attempted removal of an epidural catheter, the primary rn encountered resistance on the initial pull.The patient was repositioned and a second removal attempt was made, again meeting resistance.A second rn assisted, and additional attempts were made with patient repositioning, but resistance persisted.Anesthesia was consulted to assist with catheter removal.Upon evaluation, anesthesia also encountered resistance despite repositioning.Additional traction was applied during removal, at which time the catheter fractured, resulting in retention of a portion of the catheter.Subsequent imaging demonstrated a retained epidural catheter fragment near the superior margin of the l3 spinous process, slightly left of midline, entirely within the paraspinal soft tissue.After consultation with neurosurgery, the decision was made to manage the patient conservatively with observation and follow-up in two months.The patient was discharged home without surgical removal of the retained catheter fragment".

• Brand Name: ARROW EPIDURAL CATHETERIZATION KIT
• Common Device Name: ANESTHESIA CONDUCTION KIT
• 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 27560
• MDR Report Key: 24250872
• Report Number: 9680794-2026-00047
• Device Sequence Number: 8326578
• Product Code: CAZ
• UDI-Device Identifier: 40801902014403
• UDI-Public: (01)40801902014403(11)250806(17)270731(10)33F25G0156(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K103658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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 Catalogue Number: WJ-05401
• Device Lot Number: 33F25G0156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2025
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown