MAUDE Adverse Event Report: BD SWITZERLAND SÀRL MAXZERO; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MZ5307
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Looks like a manufacturer error.Tubing is cut on the patient connector side.Does not have a connector port.

• Brand Name: MAXZERO
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD SWITZERLAND SÀRL; 10020 pacific mesa blve; san diego CA 92121
• MDR Report Key: 25111070
• Report Number: 25111070
• Device Sequence Number: 13324292
• Product Code: FPA
• UDI-Device Identifier: 10885403230608
• UDI-Public: (01)10885403230608
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/28/2026
• Report Date (Section F): 04/28/2026

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: MZ5307
• Device Catalogue Number: MZ5307
• Device Lot Number: 25085870
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/28/2026