MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL CONTINUOUS TRAYS; ANESTHESIA CONDUCTION KIT

Catalog Number	4934-18
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received for investigation, two continuous epidural trays (one used and one unopened).Visual inspection with unaided eye showed the used catheter was severed on the proximal end.The complaint description indicates that no product quality issues were observed by the user prior to application on the patient and that the product was compromised during removal of the catheter from patient.The complaint was confirmed however the root cause could not be established.No further action will be conducted at this time.Complaint information will continue to be monitored for any new information or adverse trends and further actions taken accordingly.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.
Event or Problem Description
It was reported that epidural catheter was removed, and tip was not intact.It was broken at some point in time, and not present at removal, approximate 5cm left in patient.After consulting with a neurosurgeon, it was decided that no further investigations or interventions be performed at that time unless the patient becomes symptomatic with either pain, discomfort, or signs of infection, patient agreeable with plan.

• Brand Name: PORTEX EPIDURAL CONTINUOUS TRAYS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23348286
• Report Number: 3012307300-2025-11589
• Device Sequence Number: 15469939
• Product Code: CAZ
• UDI-Device Identifier: 00351688025350
• UDI-Public: (01)00351688025350(17)290221(10)4464829
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K965017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 4934-18
• Device Lot Number: 4464829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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
• Patient Age: 26 YR
• Patient Sex: Female