MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY/CAREFUSION303, INC. MAXZERO; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MZ1000-07

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2020

Event Type  malfunction  

Event Description

Bd 3ml syringe molding defect resulting in leaks when using the bd 3ml syringe infusions in the neonatal icu; problem occurred (b)(6) through (b)(6) 2020; multiple product lots involved.Fda safety report id#: (b)(4).

• Brand Name: MAXZERO
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY/CAREFUSION303, INC.
• MDR Report Key: 9982636
• MDR Text Key: 188691970
• Report Number: MW5094202
• Device Sequence Number: 6
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/16/2020
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MZ1000-07
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/16/2020
• 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
• Patient Outcome(s): Other