• 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
2017 53 53
2018 45 45
2019 57 57
2020 110 110
2021 108 108
2022 72 72

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 116 116
Leak/Splash 38 38
Suction Problem 29 29
Device Damaged Prior to Use 27 27
Unsealed Device Packaging 16 16
Break 15 15
Decrease in Suction 15 15
Deformation Due to Compressive Stress 14 14
Tear, Rip or Hole in Device Packaging 13 13
Component Missing 11 11
Material Twisted/Bent 11 11
Adverse Event Without Identified Device or Use Problem 11 11
Material Deformation 11 11
Suction Failure 11 11
Insufficient Information 10 10
Material Integrity Problem 9 9
Burst Container or Vessel 9 9
Air Leak 8 8
Backflow 8 8
Crack 8 8
Detachment of Device or Device Component 8 8
Device Operates Differently Than Expected 8 8
Mechanical Problem 6 6
Appropriate Term/Code Not Available 6 6
Complete Blockage 5 5
Activation, Positioning or SeparationProblem 5 5
Gas Leak 5 5
Filling Problem 4 4
Obstruction of Flow 4 4
Collapse 4 4
Delivered as Unsterile Product 4 4
Use of Device Problem 4 4
Noise, Audible 4 4
Detachment Of Device Component 3 3
Improper Flow or Infusion 3 3
Infusion or Flow Problem 3 3
Filtration Problem 2 2
Device Difficult to Maintain 2 2
Packaging Problem 2 2
Structural Problem 2 2
Defective Device 2 2
Malposition of Device 2 2
Connection Problem 2 2
Contamination 2 2
Disconnection 2 2
Material Fragmentation 2 2
Device Markings/Labelling Problem 2 2
Air/Gas in Device 2 2
Illegible Information 1 1
Missing Information 1 1
Component Misassembled 1 1
Material Split, Cut or Torn 1 1
Device Fell 1 1
Labelling, Instructions for Use or Training Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Fitting Problem 1 1
Failure to Run on Battery 1 1
Difficult To Position 1 1
Failure to Power Up 1 1
Device Difficult to Setup or Prepare 1 1
Product Quality Problem 1 1
Material Rupture 1 1
Material Separation 1 1
Shelf Life Exceeded 1 1
Sticking 1 1
Inadequate or Insufficient Training 1 1
Flushing Problem 1 1
Occlusion Within Device 1 1
Material Discolored 1 1
Chemical Spillage 1 1
Contamination /Decontamination Problem 1 1
Device Packaging Compromised 1 1
Device Dislodged or Dislocated 1 1
Expulsion 1 1
Aspiration Issue 1 1
Physical Resistance 1 1
Overfill 1 1
Positioning Problem 1 1
No Apparent Adverse Event 1 1
Device Contamination with Chemical or Other Material 1 1
Device Contamination With Biological Material 1 1
Installation-Related Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 165 165
No Consequences Or Impact To Patient 109 109
No Known Impact Or Consequence To Patient 57 57
Pneumothorax 25 25
Insufficient Information 24 24
No Information 24 24
No Patient Involvement 19 19
No Code Available 7 7
Death 5 5
Pleural Effusion 4 4
Unspecified Infection 3 3
Dyspnea 3 3
Pain 3 3
Thrombosis 2 2
Patient Problem/Medical Problem 2 2
Bacterial Infection 2 2
Pneumonia 2 2
Respiratory Distress 1 1
Sepsis 1 1
Myocardial Infarction 1 1
Pulmonary Embolism 1 1
Arrhythmia 1 1
Aspiration/Inhalation 1 1
Cellulitis 1 1
Stroke/CVA 1 1
Chest Pain 1 1
Congestive Heart Failure 1 1
Cyanosis 1 1
Cyst(s) 1 1
Emotional Changes 1 1
Pulmonary Emphysema 1 1
Hemoptysis 1 1
Hemorrhage/Bleeding 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Post Operative Wound Infection 1 1
Weight Changes 1 1
Pericardial Effusion 1 1
Unspecified Respiratory Problem 1 1
Not Applicable 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Nov-25-2021
2 Atrium Medical Corporation II Sep-29-2021
3 Atrium Medical Corporation II Feb-15-2017
4 Medline Industries Inc II Oct-22-2019
5 TELEFLEX MEDICAL INC II Aug-03-2020
-
-