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

Model Number	MZ5309
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Iv team member inserting iv in patient.When preparing the flush and connecting the extension flush set (bd maxzero) to the iv hub, the tubing came out of the male end of the extension flush set (that connects directly to the iv site) - this is the second time this has happened to this iv nurse.Both occasions were the same lot number.

• 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: 19220513
• Report Number: 19220513
• Device Sequence Number: 12810582
• Product Code: FPA
• UDI-Device Identifier: 10885403242083
• UDI-Public: 10885403242083
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/01/2024
• Report Date (Section F): 02/01/2024

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: MZ5309
• Device Catalogue Number: MZ5309
• Device Lot Number: 23129105
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2024
• 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: 02/01/2024