MAUDE Adverse Event Report: FRESENIUS KABI DEUTSCHLAND GMBH K-ZERO; NEEDLELESS CONNECTOR

Model Number	U1040246000
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: on (b)(6) 2025 fenwal international qe complaints engineer received a [fresenius kabi] ivenix complaint/disposable for evaluation and during evaluation they found a defect with a blonie product.No adverse event reported no sample available pictures available finding: during sample evaluation the cap was found to be separated from y-port.Cracked cap.Note: this was a k-zero connector on a fresenius kabi ivenix administration set.

• Brand Name: K-ZERO
• Common Device Name: NEEDLELESS CONNECTOR
• Manufacturer (Section D): FRESENIUS KABI DEUTSCHLAND GMBH; 5 robert-koch-strasse; bad hersfeld, hessen 36521 ; GM 36521
• MDR Report Key: 23700009
• Report Number: 3004548776-2025-00614
• Device Sequence Number: 16017067
• Product Code: FPA
• UDI-Device Identifier: 04250273735949
• UDI-Public: 04250273735949
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2025
• Report Date (Section F): 12/02/2025

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 Model Number: U1040246000
• Device Catalogue Number: M79400849
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/03/2025
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2025
• 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: 12/02/2025