MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number 364902

Device Problems Fluid/Blood Leak (1250); Output Problem (3005)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/21/2022

Event Type  malfunction  

Event Description

When certified cardiographic technician (cct) was drawing blood after a peripheral intravenous line (piv) placed, when blood vial was removed and cct went to place another in the vacutainer, the vacutainer was gushing blood from the needle onto cct scrubs.Vacutainer ref (b)(4).

• Brand Name: BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER
• 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: 15904413
• MDR Text Key: 304687579
• Report Number: 15904413
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 364902
• Device Catalogue Number: 364902
• Device Lot Number: 2140913
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1