MAUDE Adverse Event Report: BD Switzerland Sarl MaxZero; Set, administration, intravascular

Model Number	MZ9267
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The collar on maxzero microbore extension set syringe tubing broke off necessitating iv tubing set replacement.No harm to patient.Broken set discarded at time of event.

• Brand Name: MaxZero
• Common Device Name: Set, administration, intravascular
• Manufacturer (Section D): BD Switzerland Sarl; 3750 torrey view court; san diego CA 92130
• MDR Report Key: 50945377
• Report Number: 50945377
• Device Sequence Number: 21207078
• Product Code: FPA
• UDI-Device Identifier: 10885403240720
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/22/2026
• Report Date (Section F): 09/22/2026

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
• Operator of Device: Health Professional
• Device Model Number: MZ9267
• Device Catalogue Number: MZ9267
• Device Lot Number: 26035453
• 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: 09/30/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2026
• 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: Male
• Date Report Sent to FDA: 09/22/2026