MAUDE Adverse Event Report: CAREFUSION/BD INFUSION SET

Model Number	10013361T
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/19/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Patient seen at outpatient infusion center (b)(6) to receive bevacizumab infusion.Rn starting infusion on patient noticed leaking from the infusion set where the flexible tubing attaches to the endcap just prior to the texium connector.Rn returned to pharmacy for new set up prior to beginning infusion.Infusion set bd 10013361t; lot # 16126804.Actual tubing set was discarded due to leaking contents but lot # noted.This is same location of defect on the same infusion set reported by (b)(6) reported separately.

• Brand Name: INFUSION SET
• Common Device Name: INFUSION SET
• Manufacturer (Section D): CAREFUSION/BD; san diego CA
• MDR Report Key: 6600865
• Report Number: MW5070085
• Device Sequence Number: 789221
• Product Code: FPA
• UDI-Device Identifier: 10885403223204
• UDI-Public: (01)10885403223204
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2019
• Device Model Number: 10013361T
• Device Lot Number: 16126804
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 68