MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BC BACTEC PLUS AEROBIC/F CULTURE; SYSTEM, BLOOD CULTURING

Model Number 8089076(04)

Device Problem Material Discolored (1170)

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

Event Date 08/23/2019

Event Type  Injury  

Event Description

Blood collection vials have discolored indicator.Should be brown, some have been discovered to be orange.Fda safety report id# (b)(4).

• Brand Name: BC BACTEC PLUS AEROBIC/F CULTURE
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; sparks MD 21152
• MDR Report Key: 8939537
• MDR Text Key: 155956774
• Report Number: MW5089370
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420239
• UDI-Public: (01)00382904420239(VARIOUS)
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/26/2019
• 9 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 8089076(04)
• Device Catalogue Number: 442023
• Device Lot Number: 9086832(9 TOTAL LOT NUMBERS)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention