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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
2014 43 43
2015 34 34
2016 77 77
2017 53 53
2018 45 45
2019 57 57
2020 110 110
2021 110 110
2022 118 118
2023 92 92
2024 63 63

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 138 138
Suction Problem 72 72
Leak/Splash 69 69
Off-Label Use 48 48
Complete Blockage 34 34
Break 33 33
Deformation Due to Compressive Stress 31 31
Device Operates Differently Than Expected 30 30
Device Damaged Prior to Use 28 28
Crack 22 22
Decrease in Suction 22 22
Air Leak 21 21
Use of Device Problem 20 20
Component Missing 16 16
Unsealed Device Packaging 16 16
Adverse Event Without Identified Device or Use Problem 16 16
Insufficient Information 16 16
Material Twisted/Bent 15 15
Suction Failure 14 14
Tear, Rip or Hole in Device Packaging 14 14
Burst Container or Vessel 14 14
Material Deformation 13 13
Gas/Air Leak 13 13
Disconnection 12 12
Collapse 11 11
Material Separation 11 11
Material Integrity Problem 11 11
Appropriate Term/Code Not Available 11 11
Detachment of Device or Device Component 10 10
Connection Problem 10 10
Backflow 10 10
Loose or Intermittent Connection 9 9
Mechanical Problem 9 9
Obstruction of Flow 8 8
Inadequate or Insufficient Training 7 7
Kinked 7 7
Filling Problem 6 6
Improper or Incorrect Procedure or Method 6 6
Defective Component 6 6
Fitting Problem 6 6
Noise, Audible 6 6
Unintended Movement 5 5
Unclear Information 5 5
Activation, Positioning or Separation Problem 5 5
Product Quality Problem 5 5
Contamination 5 5
Delivered as Unsterile Product 4 4
Fracture 4 4
Device Slipped 4 4
Defective Device 4 4
Malposition of Device 4 4
Device Dislodged or Dislocated 3 3
Infusion or Flow Problem 3 3
Packaging Problem 3 3
Improper Flow or Infusion 3 3
Filtration Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Air/Gas in Device 3 3
Material Split, Cut or Torn 3 3
Material Fragmentation 3 3
Inability to Auto-Fill 3 3
Component(s), broken 3 3
Detachment Of Device Component 3 3
Degraded 2 2
Material Rupture 2 2
Shelf Life Exceeded 2 2
Material Puncture/Hole 2 2
Device Difficult to Setup or Prepare 2 2
Structural Problem 2 2
Missing Information 2 2
Device Difficult to Maintain 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Handling Problem 2 2
Difficult to Advance 2 2
Failure to Auto Stop 2 2
Pressure Problem 2 2
Contamination /Decontamination Problem 2 2
Device Markings/Labelling Problem 2 2
Device Contamination With Biological Material 1 1
Expulsion 1 1
Device Packaging Compromised 1 1
Device-Device Incompatibility 1 1
Patient-Device Incompatibility 1 1
Aspiration Issue 1 1
Device Tipped Over 1 1
Chemical Spillage 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Installation-Related Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Compatibility Problem 1 1
Patient Device Interaction Problem 1 1
Component Misassembled 1 1
No Apparent Adverse Event 1 1
Device Fell 1 1
Illegible Information 1 1
Split 1 1
Physical Resistance 1 1
Overfill 1 1
Out-Of-Box Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 327 327
No Consequences Or Impact To Patient 135 135
No Known Impact Or Consequence To Patient 117 117
Pneumothorax 48 48
Insufficient Information 45 45
No Information 43 43
No Patient Involvement 28 28
No Code Available 15 15
Pain 9 9
Death 7 7
Dyspnea 7 7
Unspecified Infection 6 6
Low Oxygen Saturation 6 6
Pleural Effusion 4 4
Thrombosis 4 4
Aspiration/Inhalation 4 4
Respiratory Distress 3 3
Distress 3 3
Pneumonia 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Patient Problem/Medical Problem 2 2
Pulmonary Emphysema 2 2
Hemorrhage/Bleeding 2 2
Foreign body, removal of 2 2
Post Operative Wound Infection 2 2
Bacterial Infection 2 2
Cyanosis 2 2
Cyst(s) 1 1
Pulmonary Embolism 1 1
Arrhythmia 1 1
Embolism 1 1
Emotional Changes 1 1
Exposure to Body Fluids 1 1
Cardiac Arrest 1 1
Cellulitis 1 1
Stroke/CVA 1 1
Chest Pain 1 1
Congestive Heart Failure 1 1
Cardiac Tamponade 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Sepsis 1 1
Tissue Damage 1 1
Hemothorax 1 1
Hypoxia 1 1
Hemoptysis 1 1
Myocardial Infarction 1 1
Necrosis 1 1
Foreign Body In Patient 1 1
Cardiac Perforation 1 1
Blood Loss 1 1
Weight Changes 1 1
Test Result 1 1
Device Embedded In Tissue or Plaque 1 1
Not Applicable 1 1
Pericardial Effusion 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 Atrium Medical Corporation II Feb-15-2017
7 Atrium Medical Corporation II Aug-20-2013
8 DeRoyal Industries Inc II Mar-23-2023
9 DeRoyal Industries Inc II Oct-20-2014
10 DeRoyal Industries Inc II Oct-20-2010
11 Hologic, Inc II Jul-19-2016
12 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
13 Medline Industries Inc II Oct-22-2019
14 Medline Industries Inc II Nov-03-2016
15 Ohio Medical Corporation II Oct-29-2009
16 Stryker Sustainability Solutions I Jan-04-2016
17 TELEFLEX MEDICAL INC II Aug-03-2020
18 Teleflex Medical II Apr-08-2015
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