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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
Decrease in Suction 15 15
Break 15 15
Deformation Due to Compressive Stress 14 14
Tear, Rip or Hole in Device Packaging 13 13
Material Deformation 11 11
Suction Failure 11 11
Material Twisted/Bent 11 11
Component Missing 11 11
Adverse Event Without Identified Device or Use Problem 11 11
Insufficient Information 10 10
Burst Container or Vessel 9 9
Material Integrity Problem 9 9
Device Operates Differently Than Expected 8 8
Air Leak 8 8
Detachment of Device or Device Component 8 8
Crack 8 8
Backflow 8 8
Mechanical Problem 6 6
Appropriate Term/Code Not Available 6 6
Activation, Positioning or SeparationProblem 5 5
Gas Leak 5 5
Complete Blockage 5 5
Obstruction of Flow 4 4
Filling Problem 4 4
Collapse 4 4
Noise, Audible 4 4
Use of Device Problem 4 4
Delivered as Unsterile Product 4 4
Improper Flow or Infusion 3 3
Infusion or Flow Problem 3 3
Detachment Of Device Component 3 3
Contamination 2 2
Air/Gas in Device 2 2
Material Fragmentation 2 2
Packaging Problem 2 2
Filtration Problem 2 2
Structural Problem 2 2
Defective Device 2 2
Disconnection 2 2
Malposition of Device 2 2
Device Difficult to Maintain 2 2
Connection Problem 2 2
Device Markings/Labelling Problem 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Positioning Problem 1 1
Component Misassembled 1 1
Contamination /Decontamination Problem 1 1
Occlusion Within Device 1 1
Failure to Run on Battery 1 1
Material Rupture 1 1
Overfill 1 1
Flushing Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Difficult To Position 1 1
Device Difficult to Setup or Prepare 1 1
Shelf Life Exceeded 1 1
Device Dislodged or Dislocated 1 1
Material Split, Cut or Torn 1 1
No Apparent Adverse Event 1 1
Device Packaging Compromised 1 1
Expulsion 1 1
Failure to Power Up 1 1
Material Separation 1 1
Inadequate or Insufficient Training 1 1
Physical Resistance 1 1
Installation-Related Problem 1 1
Illegible Information 1 1
Missing Information 1 1
Material Discolored 1 1
Device Fell 1 1
Aspiration Issue 1 1
Chemical Spillage 1 1
Device Contamination With Biological Material 1 1
Device Contamination with Chemical or Other Material 1 1
Product Quality Problem 1 1
Sticking 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Defective Component 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
Pain 3 3
Dyspnea 3 3
Thrombosis 2 2
Bacterial Infection 2 2
Patient Problem/Medical Problem 2 2
Pneumonia 2 2
Chest Pain 1 1
Respiratory Distress 1 1
Post Operative Wound Infection 1 1
Congestive Heart Failure 1 1
Emotional Changes 1 1
Sepsis 1 1
Pericardial Effusion 1 1
Unspecified Respiratory Problem 1 1
Not Applicable 1 1
Cellulitis 1 1
Stroke/CVA 1 1
Hemoptysis 1 1
Hemorrhage/Bleeding 1 1
Myocardial Infarction 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Weight Changes 1 1
Arrhythmia 1 1
Pulmonary Emphysema 1 1
Pulmonary Embolism 1 1
Aspiration/Inhalation 1 1
Cyanosis 1 1
Cyst(s) 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
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