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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
2018 45 45
2019 57 57
2020 110 110
2021 110 110
2022 117 117

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 121 121
Leak/Splash 52 52
Deformation Due to Compressive Stress 31 31
Device Damaged Prior to Use 26 26
Suction Problem 18 18
Decrease in Suction 15 15
Unsealed Device Packaging 14 14
Material Twisted/Bent 14 14
Break 12 12
Material Deformation 11 11
Tear, Rip or Hole in Device Packaging 11 11
Suction Failure 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Gas/Air Leak 9 9
Component Missing 9 9
Backflow 9 9
Crack 9 9
Insufficient Information 9 9
Mechanical Problem 8 8
Air Leak 7 7
Detachment of Device or Device Component 7 7
Material Integrity Problem 6 6
Complete Blockage 6 6
Use of Device Problem 6 6
Defective Component 6 6
Activation, Positioning or Separation Problem 5 5
Appropriate Term/Code Not Available 5 5
Noise, Audible 4 4
Obstruction of Flow 4 4
Filling Problem 4 4
Delivered as Unsterile Product 4 4
Detachment Of Device Component 3 3
Defective Device 3 3
Connection Problem 3 3
Packaging Problem 3 3
Improper Flow or Infusion 3 3
Infusion or Flow Problem 3 3
Device Operates Differently Than Expected 3 3
Filtration Problem 2 2
Device Difficult to Maintain 2 2
Structural Problem 2 2
Collapse 2 2
Disconnection 2 2
Degraded 2 2
Improper or Incorrect Procedure or Method 2 2
Device Difficult to Setup or Prepare 2 2
Manufacturing, Packaging or Shipping 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
Decrease in Pressure 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Material Separation 1 1
Increase in Suction 1 1
Inadequate or Insufficient Training 1 1
Fitting Problem 1 1
Material Discolored 1 1
Fracture 1 1
Material Fragmentation 1 1
Labelling, Instructions for Use or Training Problem 1 1
Contamination 1 1
Burst Container or Vessel 1 1
Contamination /Decontamination Problem 1 1
Device Markings/Labelling Problem 1 1
Device Tipped Over 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Overfill 1 1
No Apparent Adverse Event 1 1
Positioning Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Device Dislodged or Dislocated 1 1
Installation-Related Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 202 202
No Consequences Or Impact To Patient 90 90
No Known Impact Or Consequence To Patient 41 41
Insufficient Information 30 30
Pneumothorax 26 26
No Information 23 23
No Patient Involvement 13 13
Unspecified Infection 5 5
No Code Available 5 5
Death 5 5
Pleural Effusion 4 4
Pneumonia 3 3
Pain 3 3
Dyspnea 3 3
Thrombosis 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Bacterial Infection 2 2
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
Low Oxygen Saturation 1 1
Pulmonary Emphysema 1 1
Pulmonary Embolism 1 1
Cyanosis 1 1
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

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