MAUDE Adverse Event Report: BD BD MAXZERO IV EXTENSION CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number MZ5307

Device Problem Unsealed Device Packaging (1444)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Break in the seal of the packaging.Fda safety report id # (b)(4).

• Brand Name: BD MAXZERO IV EXTENSION CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD
• MDR Report Key: 11855054
• MDR Text Key: 252152057
• Report Number: MW5101451
• Device Sequence Number: 1
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2023
• Device Catalogue Number: MZ5307
• Device Lot Number: (10) 20126424
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1