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

Model Number	MZ5302
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
New iv placed and labs drawn with iv start.When the syringe was removed from the maxzero there was a drop of blood at the end of the connection that had to be wiped off prior to re-accessing.A few minutes after leaving the room the family called out and told me that the maxzero had come disconnected.There was blood that had dripped onto the floor.Manufacturer response for set, administration, intravascular, maxzero (per site reporter).Suggested additional staff education.Bd has sent reps multiple times for education.Issues continue.

• Brand Name: MAXZERO
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD SWITZERLAND SARL; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 22860971
• Report Number: 22860971
• Device Sequence Number: 9339430
• Product Code: FPA
• UDI-Device Identifier: 10885403230554
• UDI-Public: (01)10885403230554
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 06/27/2025
• Report Date (Section F): 06/27/2025

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
• Device Model Number: MZ5302
• Device Catalogue Number: MZ5302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2025
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/27/2025