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

Catalog Number 10807853

Device Problems Air Leak (1008); Filtration Problem (2941)

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

Event Date 08/02/2016

Event Type  malfunction  

Event Description

Air found in tubing after filter.  tubing and syringe needed to be changed due to being unable to remove air from line.  tubing was saved and given to supervisor.

• Brand Name: VERSASAFE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 6245322
• MDR Text Key: 64643493
• Report Number: 6245322
• 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: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 10807853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1