MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S EPIDURAL MINIPACK SYSTEM; ANESTHESIA CONDUCTION KIT

Catalog Number	100/391/118
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that leakage was found on the white filter while the catheter had inside the body.There was no medical intervention required.The problem was resolved by replacing a new set.There was a patient involvement, and no patient harm or adverse events reported as a result of the event.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
H3: no device or device photo was returned for investigation.Due to this, no root cause was determined.The device history review of the reported lot number found no non-conformities during the manufacturing process.If the product is returned, this complaint will be reopened for further investigation.

• Brand Name: EPIDURAL MINIPACK SYSTEM
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21734361
• Report Number: 3012307300-2025-03548
• Device Sequence Number: 18301530
• Product Code: CAZ
• UDI-Device Identifier: 15019315023460
• UDI-Public: (01)15019315023460(17)290228(10)4461198
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

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: 100/391/118
• Device Lot Number: 4461198
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2024
• 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 Sex: Unknown