MAUDE Adverse Event Report: CAREFUSION; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 30204E

Device Problems Air Leak (1008); Hole In Material (1293)

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

Event Date 03/10/2016

Event Type  malfunction  

Event Description

Upon accessing patient's ivad, rn noticed that there was air drawing out of extension tubing as well as blood.Upon inspection a small hole was noticed near the plastic luer lock connection.

• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 5572960
• MDR Text Key: 42583995
• Report Number: 5572960
• 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: 03/25/2016,04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 30204E
• Device Lot Number: 15115428
• Other Device ID Number: H37030204E16
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/25/2016
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR