MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number 367324

Device Problem Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 11/10/2022

Event Type  malfunction  

Event Description

When drawing the patient's blood, the blood came out where the hub of the vacutainer and butterfly meet.They were fully screwed together.The vacutainer lot# 2207003 and the butterfly lot# 2187210.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 16263415
• MDR Text Key: 308374077
• Report Number: 16263415
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673242
• UDI-Public: (01)50382903673242
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 367324
• Device Catalogue Number: 367324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14600 DA
• Patient Sex: Male