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

Model Number	MZ5302
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
New iv placed on pt and labs drawn during iv start.The new iv extension set was used when the syringe full of blood was removed the clave had a drop of blood on it that had to be wiped off prior to being re-accessed.Manufacturer response for set, administration, intravascular, maxzero (per site reporter).Manufacturer suggested more staff education.Education provided.Issues continue.Blood coming out of the end of the maxzero puts staff at a risk for exposure.

• 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: 22860756
• Report Number: 22860756
• Device Sequence Number: 9359584
• 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): 06/30/2025
• Report Date (Section F): 06/30/2025

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: 06/30/2025