MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD VACUTAINER; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2797

Device Problem Break (1069)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 10/08/2021

Event Type  malfunction  

Event Description

Placed vacutainer at end of 20ga iv line to obtain blood.Vacutainer broke off at iv connector site.Unable to remove vacutainer from the line.Line had to be removed.This resulted in a delay in care for a patient to receive emergent iv fluids with a blood pressure of 78/41.

• Brand Name: BD VACUTAINER
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12680814
• MDR Text Key: 277923375
• Report Number: 12680814
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2797
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30660 DA