MAUDE Adverse Event Report: Fresenius Kabi Deutschland GmbH K-Zero; Needleless Connector

Model Number	M79400849Y
Medical Device Problem Codes	Break (1069); Leak/Splash (1354); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Cases of detachment/fracture between the transparent and coloured components of the check valve have been reported, resulting in blood leakage due to backflow or leakage of the intravenous therapy being administered.Furthermore, several samples were found to be occluded and unusable upon opening of the primary packaging.

• Brand Name: K-Zero
• Common Device Name: Needleless Connector
• Manufacturer (Section D): Fresenius Kabi Deutschland GmbH; 5 robert-koch-strasse; bad hersfeld, 3D-62 51; GM 3D-6251
• MDR Report Key: 50603296
• Report Number: 3004548776-2026-00375
• Device Sequence Number: 13444768
• Product Code: FPA
• UDI-Device Identifier: 04250273735949
• UDI-Public: 04250273735949
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

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 Model Number: M79400849Y
• Device Catalogue Number: M79400849Y
• Device Lot Number: 32092275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/03/2026