MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX EPIDURAL CONTINUOUS TRAYS; ANESTHESIA CONDUCTION KIT

Catalog Number	24-1327-22
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when connecting the filter and catheter tube, it has been noticed that the threads in the yellow connector do not engage properly, and the connection can be pulled apart, potentially leading to contamination of the set and, in worst case, an infection in the epidural space.This could have caused death or severe health deterioration.There was no impact on the patient as this was discovered in time and a new filter with a functional connector could be used.
Additional Manufacturer Narrative
D4: full udi not available as no lot number was provided.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
H6.Investigation codes: updated.Investigation summary: one used decontaminated sample of 30-4451 filter, 0.2 micron, iso neuraxial f/m, rotating hub was received without its original packaging for investigation.Customer is claiming that the threads in the yellow connector do not engage properly, and the connection can be pulled apart.Sample provided by customer was visually inspected with no problem found, so the sample was tested by connecting the filter with the connector and then slightly pulled to see if the filter will detach or not.On video you can see that the tested sample is connected successfully and then after pulling the components did not detach.Based on the event description and samples condition the disconnection was probably caused when the customer did not follow the instructions for use.No trend of similar customer complaints has been identified.A device history record could not be completed as no lot number was received.

• Brand Name: PORTEX EPIDURAL CONTINUOUS TRAYS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A. S; olomoucká 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20864293
• Report Number: 3011237704-2024-00271
• Device Sequence Number: 8592679
• Product Code: CAZ
• UDI-Device Identifier: 15019517075595
• UDI-Public: (01)15019517075595
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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: 24-1327-22
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown