MAUDE Adverse Event Report: BD SMARTSITE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 20039E

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 10/30/2020

Event Type  malfunction  

Event Description

Smartsite extension set failed when attaching to angiocath during piv start.No blood return obtained on a good piv.Replaced with new extension set and worked fine.Fda safety report id # (b)(4).

• Brand Name: SMARTSITE EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD
• MDR Report Key: 10816573
• MDR Text Key: 216340924
• Report Number: MW5097764
• 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: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2023
• Device Catalogue Number: 20039E
• Device Lot Number: 20096345
• 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: 84 YR