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

Model Number MP5303-C

Device Problems Difficult to Flush (1251); Product Quality Problem (1506); Improper Flow or Infusion (2954)

Patient Problems Abdominal Pain (1685); Chest Pain (1776)

Event Date 04/07/2023

Event Type  malfunction  

Event Description

Mid 40¿s female with recent epigastric and chest pain.Loop attached to new iv site and it would not flush or withdraw blood.New one used without known harm to patient.This is the 4th report for this product.

• Brand Name: MAXPLUS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 16742280
• MDR Text Key: 313308720
• Report Number: 16742280
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403236655
• UDI-Public: (01)10885403236655(10)22089414(17)20270823
• 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: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MP5303-C
• Device Catalogue Number: MP5303-C
• Device Lot Number: 22089414
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/07/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/14/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16060 DA
• Patient Sex: Female
• Patient Weight: 80 KG