MAUDE Adverse Event Report: CAREFUSION 303, INC. AS LVP 20D 1.2M; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2202-0007

Device Problem Gas/Air Leak (2946)

Patient Problem Irritability (2421)

Event Date 11/16/2020

Event Type  No Answer Provided  

Event Description

Patient's picc line tubing was changed in evening for line change day.Patient was fussy and while trying to settle baby discovered air bubble that was significantly large at the base of filter.Filter was not functioning properly and bubbles were passing through.Had to pull from the line to remove air bubble.

• Brand Name: AS LVP 20D 1.2M
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 11100360
• MDR Text Key: 224531367
• Report Number: 11100360
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2202-0007
• Device Catalogue Number: 2202-0007
• Device Lot Number: 20075125
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/31/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 DA