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	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the yellow lock causes the catheter to become completely blocked when secured in place, resulting in a re-site of the labor epidural.Reporter stated that, on opening the epidural pack, the yellow end comes out of the pack only half opened, and when the user threads it into the device when it is still in the half-opened position, closes the clamp and tries to flush, they experienced a blocked catheter.Reporter stated that, if the yellow end bit is fully opened (wings extended) before the catheter is threaded, then when closed it more often than not flushes correctly.As the patient had to be re-sited, there was a delay in achieving the required pain relief.
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 information becomes available.
Additional Manufacturer Narrative
One device was returned for analysis of complaint that the yellow lock causes complete catheter occlusion once secured, although the catheter itself remains patent.Under visual inspection the sample appeared to be in good condition.Functional testing was performed.Visual examination was done by marking the catheter by black marker near closed connector.Then the connector was opened and the length of catheter which was inserted in connectors by customer was compared with length of the connector sleeve.The comparison shows that catheter was not fully inserted into the connector before use which resulted in reported issues.Catheter functionality was tested, and it was confirmed that no occlusion was identified when catheter is fully inserted in connector.No signal of confirmed customer complaints related to this failure was identified.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 lot number.One other customer complaint was received against affected lot number which is describing the same issue and has not been confirmed.

• 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: 23037659
• Report Number: 3012307300-2025-10570
• Device Sequence Number: 18437091
• Product Code: CAZ
• UDI-Device Identifier: 15019517075335
• UDI-Public: (01)15019517075335(17)300319(10)6096227
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: 24-1300-22
• Device Lot Number: 6096227
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2025
• 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