MAUDE Adverse Event Report: CAREFUSION SMARTSITE INFUSION SET

Model Number 2420-0500

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293); Chemical Spillage (2894)

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

Event Date 06/11/2014

Event Type  malfunction  

Event Description

Tubing connected to chemotherapy had a hole in it and was leaking chemotherapy out of tubing.Hooked to equashield closed system transfer device and to baxter d5w 250ml, but the tubing was clearly damaged.I have pictures.

• Brand Name: SMARTSITE INFUSION SET
• Type of Device: INFUSION SET
• Manufacturer (Section D): CAREFUSION; rolle ; SZ
• MDR Report Key: 3877448
• MDR Text Key: 4567743
• Report Number: MW5036636
• 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: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 2420-0500
• Device Lot Number: 14015952
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EQUASHIELD CLOSED SYSTEM TRANSFER DEVICE; BAXTER D5W 250ML
• Patient Age: 66 YR
• Patient Weight: 86