MAUDE Adverse Event Report: CAREFUSION SMARTSITE INFUSION SET

Lot Number 13105099

Device Problems Leak/Splash (1354); Chemical Spillage (2894)

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

Event Date 03/05/2014

Event Type  No Answer Provided  

Event Description

Twenty ml of docetaxel (chemo) leaked out from the connection between the infusion set and female luer lock closed system transfer device.Reason for use: to infuse docetaxel.Infuse docetaxel to patient.

• Brand Name: SMARTSITE INFUSION SET
• Type of Device: SMARTSITE INFUSION
• Manufacturer (Section D): CAREFUSION
• MDR Report Key: 3675346
• MDR Text Key: 4301515
• Report Number: MW5034887
• Device Sequence Number: 1
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/06/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 13105099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 64