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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
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 124 124

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 140 140
Suction Problem 88 88
Leak/Splash 71 71
Off-Label Use 56 56
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
Decrease in Suction 24 24
Crack 24 24
Use of Device Problem 21 21
Air Leak 21 21
Suction Failure 20 20
Material Deformation 17 17
Adverse Event Without Identified Device or Use Problem 17 17
Component Missing 16 16
Unsealed Device Packaging 16 16
Insufficient Information 16 16
Material Twisted/Bent 15 15
Tear, Rip or Hole in Device Packaging 14 14
Burst Container or Vessel 14 14
Gas/Air Leak 13 13
Appropriate Term/Code Not Available 12 12
Disconnection 12 12
Collapse 11 11
Material Separation 11 11
Material Integrity Problem 11 11
Connection Problem 10 10
Detachment of Device or Device Component 10 10
Backflow 10 10
Loose or Intermittent Connection 9 9
Mechanical Problem 9 9
Inadequate or Insufficient Training 8 8
Obstruction of Flow 8 8
Improper or Incorrect Procedure or Method 7 7
Kinked 7 7
Fitting Problem 7 7
Noise, Audible 6 6
Filling Problem 6 6
Defective Component 6 6
Unintended Movement 5 5
Activation, Positioning or Separation Problem 5 5
Fracture 5 5
Unclear Information 5 5
Product Quality Problem 5 5
Contamination 5 5
Device Slipped 4 4
Unexpected Color 4 4
Delivered as Unsterile Product 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 377 377
No Consequences Or Impact To Patient 135 135
No Known Impact Or Consequence To Patient 117 117
Insufficient Information 54 54
Pneumothorax 48 48
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
Aspiration/Inhalation 5 5
Thrombosis 4 4
Pleural Effusion 4 4
Distress 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Pneumonia 3 3
Respiratory Distress 3 3
Pulmonary Emphysema 3 3
Hemorrhage/Bleeding 2 2
Bacterial Infection 2 2
Post Operative Wound Infection 2 2
Foreign body, removal of 2 2
Patient Problem/Medical Problem 2 2
Cyanosis 2 2
Blood Loss 1 1
Pericardial Effusion 1 1
Cardiac Arrest 1 1
Cellulitis 1 1
Cardiac Tamponade 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Hemoptysis 1 1
Unspecified Blood or Lymphatic problem 1 1
Cardiac Perforation 1 1
Foreign Body In Patient 1 1
Exposure to Body Fluids 1 1
Chest Pain 1 1
Cyst(s) 1 1
Test Result 1 1
Vomiting 1 1
Necrosis 1 1
Respiratory Arrest 1 1
Not Applicable 1 1
Laceration(s) 1 1
Sepsis 1 1
Emotional Changes 1 1
Congestive Heart Failure 1 1
Embolism 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 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
13 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
14 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
15 Medline Industries Inc II Oct-22-2019
16 Medline Industries Inc II Nov-03-2016
17 Ohio Medical Corporation II Oct-29-2009
18 Stryker Sustainability Solutions I Jan-04-2016
19 TELEFLEX MEDICAL INC II Aug-03-2020
20 Teleflex Medical II Apr-08-2015
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