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

Model Number MP1000-C

Device Problems Leak/Splash (1354); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 03/22/2019

Event Type  Injury  

Event Description

Maxplus needle free connector malfunction.Valve is leaking.Dates of use: (b)(6) 2019 - (b)(6) 2019.Diagnosis or reason for use: needle free connector on midline catheter hub.

• Brand Name: MAXPLUS NEEDLE FREE CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.
• MDR Report Key: 8456092
• MDR Text Key: 140147455
• Report Number: MW5085182
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403223228
• UDI-Public: 0110885403223228
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MP1000-C
• Device Catalogue Number: MP1000-C
• Was Device Available for Evaluation?: Yes
• 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): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 87