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

Catalog Number	24-1301-22
Medical Device Problem Codes	Complete Blockage (1094); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 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.
Event or Problem Description
It was reported that while trying to assure epidural space, there was a loss of resistance to saline, as it couldn¿t pass through the catheter.After removing the catheter, they confirmed the tuohy position using the lor saline syringe, injecting more saline to open up the space and tried again with a new catheter.They eventually managed to pass it, continuously injecting saline via the catheter, but with quite a bit of difficulty.When they removed the tuohy needle, the tip was bent over, which would explain the resistance and catching issues.The operator of the device was a health professional staff.The outcome of the event is that the epidural worked well and provided effective pain relief for the woman during labor.There was patient involvement, but no patient harm.
Additional Manufacturer Narrative
No product samples, pictures, or videos were received for the investigation.The complaint of catheter tip being bent over could not be confirmed by investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.There was not raised any other customer complaint against reported lot number.

• 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23882858
• Report Number: 3012307300-2025-13731
• Device Sequence Number: 4771916
• Product Code: CAZ
• UDI-Device Identifier: 15019517073935
• UDI-Public: (01)15019517073935(17)290807(10)6038396
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 01/22/2026

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: 24-1301-22
• Device Lot Number: 6038396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2024
• 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