MAUDE Adverse Event Report: ICU MEDICAL CZECH REPUBLIC A. S PORTEX EPIDURAL NRFIT CONNECTOR, MINIPACK, TUOHY NDL, CONTINUOUS TRAYS; ANESTHESIA CONDUCTION KIT

Catalog Number	24-1300-22
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the epidural catheter was inserted in a patient and secured using the lockit fixation device.On the following day, the patient was noted to have a major epidural leak, resulting in ineffective analgesia.The catheter was subsequently removed and was found to be fractured at the point where it had passed through the lockit device.There was patient involvement, but no patient harm other than inadequate analgesia.

• Brand Name: PORTEX EPIDURAL NRFIT CONNECTOR, MINIPACK, TUOHY NDL, CONTINUOUS TRAYS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ICU 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 ; +1(224)706-2300
• MDR Report Key: 24366248
• Report Number: 3012307300-2026-01349
• Device Sequence Number: 5315453
• Product Code: CAZ
• UDI-Device Identifier: 15019517075335
• UDI-Public: (01)15019517075335(17)280504(10)6096258
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2026

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: 24-1300-22
• Device Lot Number: 6096258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2025
• 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
• Patient Sex: Unknown