MAUDE Adverse Event Report: Fresenius Kabi AG Ivenix, Inc.; Set, Administration, Intravascular

Model Number	SET-0014-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Blood bag tubing broke when getting spiked to be used by nursing staff.Our health system has had 10 of the events reported across multiple sites.Per our lab manager, this is contributing to wasted blood amidst a blood shortage.

• Brand Name: Ivenix, Inc.
• Common Device Name: Set, Administration, Intravascular
• Manufacturer (Section D): Fresenius Kabi AG; three corporate drive; lake zurich IL 60047
• MDR Report Key: 50754386
• Report Number: 50754386
• Device Sequence Number: 9550959
• Product Code: FPA
• UDI-Device Identifier: 00811505030030
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2026
• Report Date (Section F): 07/28/2026

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
• Device Model Number: SET-0014-1
• Device Catalogue Number: SET-0014-1
• Device Lot Number: FA26A12045
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/28/2026