BBL VACUTAINER *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-03 for BBL VACUTAINER * manufactured by Becton Dickinson.

Event Text Entries

[2960017] Three of the anaerobic specimen tubes broke during normal use. Also, it appeared there was moisture inside the tubes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2862304
• MDR Report Key: 2862304
• Date Received: 2012-12-03
• Date of Report: 2012-12-03
• Date of Event: 2012-11-30
• Report Date: 2012-12-03
• Date Reported to FDA: 2012-12-03
• Date Added to Maude: 2012-12-07
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: BBL VACUTAINER
• Generic Name: TRANSPORT SYSTEMS, ANAEROBIC
• Product Code: JTX
• Date Received: 2012-12-03
• Model Number: *
• Catalog Number: *
• Lot Number: 2061411
• ID Number: *
• Operator: NURSE
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BECTON DICKINSON
• Manufacturer Address: 7 LOVETON CIRCLE SPARKS MD 21152 US 21152

Device Sequence Number: 2

• Brand Name: BBL VACUTAINER
• Generic Name: TRANSPORT SYSTEMS, ANAEROBIC
• Product Code: JTX
• Date Received: 2012-12-03
• Model Number: *
• Catalog Number: *
• Lot Number: 2146020
• ID Number: *
• Device Availability: Y
• Device Age: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: BECTON DICKINSON
• Manufacturer Address: 7 LOVETON CIRCLE SPARKS MD 21152 US 21152

Device Sequence Number: 3

• Brand Name: BBL VACUTAINER
• Generic Name: TRANSPORT SYSTEMS, ANAEROBIC
• Product Code: JTX
• Date Received: 2012-12-03
• Model Number: *
• Catalog Number: *
• Lot Number: 1242294
• ID Number: *
• Device Availability: Y
• Device Age: *
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: BECTON DICKINSON
• Manufacturer Address: 7 LOVETON CIRCLE SPARKS MA * US *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-12-03