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

Catalog Number 20039E

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 10/26/2020

Event Type  malfunction  

Event Description

Had a smartsite extension set fail when i placed iv.Could not get blood return.Switched to a new one and was able to obtain blood return easily.Fda safety report id# (b)(4).

• Brand Name: SMARTSITE EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD / CAREFUSION 303, INC.
• MDR Report Key: 10755616
• MDR Text Key: 213918178
• Report Number: MW5097540
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/20/2023
• Device Catalogue Number: 20039E
• Device Lot Number: 20076799
• 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
• Patient Age: 72 YR