MAUDE Adverse Event Report: BD / CAREFUSION 303, INC. BD SMARTSITE EXTENSION; SET, ADMINISTRATION, INTRAVASCULAR

Model Number REF: 20039E

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 04/16/2021

Event Type  malfunction  

Event Description

Smartsite extension set faulty, would not draw back blood.Fda safety report id # (b)(4).

• Brand Name: BD SMARTSITE EXTENSION
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD / CAREFUSION 303, INC. ; san diego CA
• MDR Report Key: 11705934
• MDR Text Key: 247007622
• Report Number: MW5100922
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2023
• Device Model Number: REF: 20039E
• Device Lot Number: 20126088
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1