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

Model Number MX5301

Device Problems Fluid/Blood Leak (1250); Improper Flow or Infusion (2954)

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

Event Date 03/05/2023

Event Type  malfunction  

Event Description

Registered nurse starting iv on patient who is here this morning for scheduled cesarean section.Iv placed on right arm without difficulty, used bd max guard pressure rated extension set with needleless y site.Once connected to iv line, blood dripping out of the connection port where extension set connects to regular iv tubing.Nurse double checked connection making sure it was tightened completely and continued to leak.Care was paused to replace the maxguard extension set, and currently appears to be functioning without leaks.Lot # 22099253 with expiration date 2025-09-13 we have had 2 other issues with this same lot number of these bd maxguard extension sets.The manufacturers have reached out to me and asked for the specific malfunctioning sites, but the nurse didn't collect it.The other events were regarding these extension sets not flowing properly, but they didn't leak.

• Brand Name: MAXGUARD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 16627103
• MDR Text Key: 312127692
• Report Number: 16627103
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MX5301
• Device Catalogue Number: MX5301
• Device Lot Number: 22099253
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12410 DA
• Patient Sex: Female
• Patient Weight: 69 KG