• 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 bottle, collection, vacuum
Product CodeKDQ
Regulation Number 880.6740
Device Class 2

MDR Year MDR Reports MDR Events
2019 57 57
2020 110 110
2021 110 110
2022 118 118
2023 92 92
2024 74 74

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 123 123
Leak/Splash 52 52
Off-Label Use 49 49
Suction Problem 33 33
Complete Blockage 32 32
Deformation Due to Compressive Stress 31 31
Device Damaged Prior to Use 25 25
Decrease in Suction 21 21
Use of Device Problem 19 19
Material Twisted/Bent 15 15
Unsealed Device Packaging 14 14
Suction Failure 14 14
Component Missing 13 13
Gas/Air Leak 13 13
Tear, Rip or Hole in Device Packaging 12 12
Material Deformation 11 11
Crack 9 9
Break 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Insufficient Information 8 8
Appropriate Term/Code Not Available 8 8
Detachment of Device or Device Component 7 7
Disconnection 7 7
Mechanical Problem 7 7
Defective Component 6 6
Inadequate or Insufficient Training 6 6
Obstruction of Flow 6 6
Material Integrity Problem 6 6
Unintended Movement 5 5
Activation, Positioning or Separation Problem 5 5
Product Quality Problem 5 5
Filling Problem 5 5
Unclear Information 5 5
Improper or Incorrect Procedure or Method 4 4
Fitting Problem 4 4
Material Discolored 4 4
Delivered as Unsterile Product 4 4
Defective Device 4 4
Noise, Audible 4 4
Infusion or Flow Problem 3 3
Packaging Problem 3 3
Connection Problem 3 3
Inability to Auto-Fill 3 3
Backflow 3 3
Material Split, Cut or Torn 3 3
Air/Gas in Device 3 3
Missing Information 2 2
Degraded 2 2
Fracture 2 2
Material Fragmentation 2 2
Melted 2 2
Device Difficult to Setup or Prepare 2 2
Material Puncture/Hole 2 2
Filtration Problem 2 2
Improper Flow or Infusion 2 2
Contamination /Decontamination Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Component Misassembled 2 2
Device Difficult to Maintain 2 2
Device Handling Problem 2 2
No Apparent Adverse Event 1 1
Patient Device Interaction Problem 1 1
Pressure Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Installation-Related Problem 1 1
Overfill 1 1
Device Tipped Over 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Device Markings/Labelling Problem 1 1
Device Dislodged or Dislocated 1 1
Decrease in Pressure 1 1
Material Separation 1 1
Increase in Suction 1 1
Labelling, Instructions for Use or Training Problem 1 1
Loose or Intermittent Connection 1 1
Partial Blockage 1 1
Burst Container or Vessel 1 1
Illegible Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 335 335
No Consequences Or Impact To Patient 85 85
Insufficient Information 47 47
No Known Impact Or Consequence To Patient 35 35
Pneumothorax 27 27
No Information 9 9
No Patient Involvement 8 8
Pain 7 7
Death 3 3
No Code Available 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Distress 3 3
Low Oxygen Saturation 2 2
Unspecified Infection 2 2
Aspiration/Inhalation 2 2
Bacterial Infection 2 2
Cardiac Arrest 1 1
Stroke/CVA 1 1
Cyanosis 1 1
Dyspnea 1 1
Hypoxia 1 1
Pneumonia 1 1
Unspecified Blood or Lymphatic problem 1 1
Aspiration Pneumonitis 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 1 1
Unspecified Respiratory Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Dec-02-2023
2 Atrium Medical Corporation II Mar-30-2023
3 Atrium Medical Corporation II Nov-15-2022
4 Atrium Medical Corporation II Nov-25-2021
5 Atrium Medical Corporation II Sep-29-2021
6 DeRoyal Industries Inc II Mar-23-2023
7 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
8 Medline Industries Inc II Oct-22-2019
9 TELEFLEX MEDICAL INC II Aug-03-2020
-
-