MAUDE Adverse Event Report: CAREFUSION 303, INC. BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE AND STOPCOCK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MX4450

Device Problems Failure to Prime (1492); Obstruction of Flow (2423)

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

Event Date 02/28/2023

Event Type  malfunction  

Event Description

5 reports where the maxguard extension sets do not prime as a patient is being prepared for surgery.Multiple reports of attempting to prime for patient care and iv fluid set up for surgery and the sets do not prime with fluid, there is some kind of occlusion within the set.Bd rep will come and assist staff re issue.

• Brand Name: BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE AND STOPCOCK
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 16901948
• MDR Text Key: 314914022
• Report Number: 16901948
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/27/2023,04/11/2023

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
• Device Model Number: MX4450
• Device Catalogue Number: REF MX4450
• Device Lot Number: 22099402
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2023
• Date Report to Manufacturer: 05/10/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1