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

Model Number MZ5305

Device Problems Detachment of Device or Device Component (2907); Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/08/2022

Event Type  malfunction  

Event 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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD BECTON DICKINSON & COMPANY
• MDR Report Key: 15455993
• MDR Text Key: 300338272
• Report Number: MW5112142
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403230585
• UDI-Public: (01)10885403230585
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MZ5305
• Device Lot Number: (10)21125399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1