MAUDE Adverse Event Report: CAREFUSION CAREFUSION QUAD CONNECTOR; BD QUAD CONNECTOR

Catalog Number MZ9275

Device Problems Occlusion Within Device (1423); Pressure Problem (3012)

Patient Problem No Information (3190)

Event Date 11/15/2017

Event Type  malfunction  

Event Description

Carefusion (bd) quad connector ref # mz9275.Noted to be occluded after it was removed from patient after the following scenario: all ivf's/ drips/ and tubing changed.Rn notified of pressure increasing alarm, line assessed.Alarm continued.Dates of use: (b)(6) 2017.Diagnosis or reason for use: prematurity of birth.

• Brand Name: CAREFUSION QUAD CONNECTOR
• Type of Device: BD QUAD CONNECTOR
• Manufacturer (Section D): CAREFUSION; san diego CA
• MDR Report Key: 7159821
• MDR Text Key: 96384993
• Report Number: MW5074373
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Catalogue Number: MZ9275
• Device Lot Number: 576254
• 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 Age: 1 WK
• Patient Weight: 2