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

Catalog Number 48001M-05

Device Problems Air Leak (1008); Loss of or Failure to Bond (1068); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 11/07/2014

Event Type  malfunction  

Event Description

The float ball that is supposed to shut off the iv flow when the buretrol is empty malfunctioned.Upon inspection the ball was at the bottom of the drip chamber but did not create a seal, allowing 3 ml of air to enter the iv line.The air was aspirated out of the line before it could reach the patient.

• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 5369232
• MDR Text Key: 36030706
• Report Number: 5369232
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 48001M-05
• Device Lot Number: UNKNOWN
• Other Device ID Number: SET, BURETTE W/2 PREPIERCED Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1