MAUDE Adverse Event Report: CAREFUSION 303, INC. MAXZERO; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MZ1000-07

Device Problem Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 09/01/2021

Event Type  malfunction  

Event Description

Maxzero pressure-rated iv extension set needleless connector disconnected.

• Brand Name: MAXZERO
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 12487533
• MDR Text Key: 271894725
• Report Number: 12487533
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MZ1000-07
• Device Catalogue Number: MZ1000-07
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2021
• Date Report to Manufacturer: 09/17/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA