MAUDE Adverse Event Report: BD BECTON DICKINSON & COMPANY BD MAXZEROIV CONNECTOR, NO CLAMP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MZ5305
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The iv connection portion of the extension set was not secure.When attempting to secure to iv hub, the entire connection portion detached.Fda safety report id #(b)(4).

• Brand Name: BD MAXZEROIV CONNECTOR, NO CLAMP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD BECTON DICKINSON & COMPANY
• MDR Report Key: 15455993
• Report Number: MW5112142
• Device Sequence Number: 17643773
• Product Code: FPA
• UDI-Device Identifier: 10885403230585
• UDI-Public: (01)10885403230585
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

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 Expiration Date: 07/12/2024
• Device Model Number: MZ5305
• Device Lot Number: (10)21125399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown