Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 container, liquid medication, graduated
Product CodeKYW
Regulation Number 880.6430
Device Class 1

MDR Year MDR Reports MDR Events
2015 1 1
2016 1 1
2017 3 3
2018 23 23
2019 38 38
2020 24 24
2021 15 15
2022 35 35
2023 19 19
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 39 39
Device Markings/Labelling Problem 29 29
Fluid/Blood Leak 11 11
Leak/Splash 10 10
Volume Accuracy Problem 9 9
Patient Device Interaction Problem 9 9
Break 6 6
Physical Resistance/Sticking 5 5
Illegible Information 3 3
Loose or Intermittent Connection 3 3
Defective Component 3 3
Contamination /Decontamination Problem 3 3
Packaging Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Material Deformation 2 2
Appropriate Term/Code Not Available 2 2
Device Packaging Compromised 2 2
Failure to Deliver 2 2
Delivered as Unsterile Product 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Missing Information 1 1
Sharp Edges 1 1
Unsealed Device Packaging 1 1
Product Quality Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Shipping Damage or Problem 1 1
Sticking 1 1
Component Missing 1 1
Fungus in Device Environment 1 1
Device Damaged Prior to Use 1 1
Moisture Damage 1 1
Complete Blockage 1 1
Crack 1 1
Material Discolored 1 1
Disconnection 1 1
Material Disintegration 1 1
Obstruction of Flow 1 1
Expiration Date Error 1 1
Split 1 1
Patient-Device Incompatibility 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Disinfection Or Sterilization Issue 1 1
Human-Device Interface Problem 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 63 63
No Known Impact Or Consequence To Patient 60 60
No Patient Involvement 15 15
No Consequences Or Impact To Patient 9 9
Pulmonary Emphysema 5 5
No Information 3 3
Insufficient Information 2 2
Pneumonia 2 2
Pneumothorax 1 1
Choking 1 1
Underdose 1 1
Overdose 1 1
Airway Obstruction 1 1
Aspiration/Inhalation 1 1
Dyspnea 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Foreign Body In Patient 1 1
No Code Available 1 1
Reaction to Medicinal Component of Device 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Centurion Medical Products Corporation II Feb-05-2020
2 Medicina Uk Ltd II Oct-20-2022
3 Medline Industries Inc II Aug-11-2016
-
-