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	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filled 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 broke off when removing catheter and 4cm was left in patient.Catheter remains in patient, as surgery to remove decided not to be in her best interest.There was patient involvement and no adverse event or harm reported.
Additional Manufacturer Narrative
H3: the device was not returned; however, two images were received showing a catheter with a missing blue tip.No manufacturing anomalies were identified in the lot history review.Visual evaluation of the images confirmed the reported break; however, functional testing could not be performed.The complaint was confirmed based on the images, but the root cause could not be determined due to the absence of the physical sample.

• 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: 24483006
• Report Number: 3012307300-2026-01850
• Device Sequence Number: 5092196
• Product Code: CAZ
• UDI-Device Identifier: 15019517075335
• UDI-Public: (01)15019517075335(17)300805(10)6142278
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 24-1300-22
• Device Lot Number: 6142278
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female