• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device system, transport, aerobic
Regulation Description Microbiological specimen collection and transport device.
Product CodeJTW
Regulation Number 866.2900
Device Class 1

MDR Year MDR Reports MDR Events
2016 2 2
2017 14 14
2018 32 32
2019 8 8
2020 12 12
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 23 23
Device Contamination with Chemical or Other Material 10 10
Fluid Leak 8 8
Short Fill 6 6
Volume Accuracy Problem 5 5
Incorrect, Inadequate or Imprecise Resultor Readings 5 5
Delivered as Unsterile Product 4 4
Material Protrusion/Extrusion 3 3
Device Operates Differently Than Expected 2 2
Difficult to Open or Close 2 2
Component Missing 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Scratched Material 1 1
Contamination 1 1
Product Quality Problem 1 1
Device Markings/Labelling Problem 1 1
Incorrect Or Inadequate Test Results 1 1
Detachment of Device or Device Component 1 1
Use of Device Problem 1 1
Failure to Shut Off 1 1
Insufficient Information 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 48 48
No Consequences Or Impact To Patient 12 12
No Clinical Signs, Symptoms or Conditions 3 3
No Patient Involvement 3 3
No Information 2 2
Hemorrhage/Bleeding 1 1
Needle Stick/Puncture 1 1
Blood Loss 1 1
Hypersensitivity/Allergic reaction 1 1
Inflammation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Company II Nov-21-2018
-
-