MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD VACUTAINER® URINALYSIS TUBE ROUND BOTTOM

Catalog Number 364979

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913); Physical Property Issue (3008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2017

Event Type  malfunction  

Event Description

Yellow top "bd vacutainer acd solution a" and "bd vacutainer ua no additive" lab tubes appear nearly identical without close examination.Tubes can be easily mistaken for one another for lab draws.Our hospital had been experiencing leaks when transporting urine through the tube station, so we selected the bd vacutainer ua the ua tubes were inadvertently sent to one of our oncology units instead of the acd solution a vacutainer, and blood was collected in the wrong tube.

Manufacturer Narrative

The following elements have blank data.

Event Description

Yellow top "bd vacutainer acd solution a" and "bd vacutainer ua no additive" lab tubes appear nearly identical without close examination.Tubes can be easily mistaken for one another for lab draws.

• Brand Name: BD VACUTAINER® URINALYSIS TUBE ROUND BOTTOM
• Type of Device: URINALYSIS TUBE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 6841717
• MDR Text Key: 84848054
• Report Number: 6841717
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 364979
• Other Device ID Number: 700008767
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1