Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
2018 45 45
2019 57 57
2020 110 110
2021 110 110
2022 118 118
2023 69 69

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 126 126
Leak/Splash 59 59
Suction Problem 36 36
Deformation Due to Compressive Stress 31 31
Device Damaged Prior to Use 26 26
Decrease in Suction 15 15
Complete Blockage 14 14
Unsealed Device Packaging 14 14
Material Twisted/Bent 14 14
Gas/Air Leak 13 13
Tear, Rip or Hole in Device Packaging 12 12
Suction Failure 12 12
Insufficient Information 11 11
Adverse Event Without Identified Device or Use Problem 11 11
Material Deformation 11 11
Component Missing 10 10
Backflow 10 10
Break 10 10
Crack 10 10
Mechanical Problem 8 8
Use of Device Problem 7 7
Air Leak 7 7
Detachment of Device or Device Component 7 7
Material Integrity Problem 6 6
Defective Component 6 6
Off-Label Use 6 6
Appropriate Term/Code Not Available 6 6
Unintended Movement 5 5
Product Quality Problem 5 5
Activation, Positioning or Separation Problem 5 5
Defective Device 4 4
Filling Problem 4 4
Obstruction of Flow 4 4
Improper or Incorrect Procedure or Method 4 4
Delivered as Unsterile Product 4 4
Noise, Audible 4 4
Air/Gas in Device 3 3
Fitting Problem 3 3
Inability to Auto-Fill 3 3
Detachment Of Device Component 3 3
Disconnection 3 3
Connection Problem 3 3
Packaging Problem 3 3
Device Operates Differently Than Expected 3 3
Improper Flow or Infusion 3 3
Infusion or Flow Problem 3 3
Filtration Problem 2 2
Contamination /Decontamination Problem 2 2
Structural Problem 2 2
Degraded 2 2
Collapse 2 2
Material Puncture/Hole 2 2
Device Difficult to Setup or Prepare 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Missing Information 2 2
Material Split, Cut or Torn 2 2
Device Difficult to Maintain 2 2
Device Handling Problem 1 1
Device Fell 1 1
Component Misassembled 1 1
Illegible Information 1 1
Decrease in Pressure 1 1
Loose or Intermittent Connection 1 1
Material Separation 1 1
Increase in Suction 1 1
Inadequate or Insufficient Training 1 1
Contamination 1 1
Burst Container or Vessel 1 1
Material Discolored 1 1
Fracture 1 1
Material Fragmentation 1 1
Labelling, Instructions for Use or Training Problem 1 1
Overfill 1 1
Device Tipped Over 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Device Contamination with Chemical or Other Material 1 1
Pressure Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Installation-Related Problem 1 1
Device Dislodged or Dislocated 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 254 254
No Consequences Or Impact To Patient 90 90
No Known Impact Or Consequence To Patient 41 41
Insufficient Information 36 36
Pneumothorax 29 29
No Information 23 23
No Patient Involvement 13 13
Pain 8 8
Unspecified Infection 5 5
Death 5 5
No Code Available 5 5
Pleural Effusion 4 4
Pneumonia 3 3
Dyspnea 3 3
Bacterial Infection 2 2
Low Oxygen Saturation 2 2
Thrombosis 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Weight Changes 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Post Operative Wound Infection 1 1
Pericardial Effusion 1 1
Aspiration Pneumonitis 1 1
Respiratory Arrest 1 1
Unspecified Respiratory Problem 1 1
Cardiac Arrest 1 1
Cellulitis 1 1
Stroke/CVA 1 1
Chest Pain 1 1
Congestive Heart Failure 1 1
Cyanosis 1 1
Emotional Changes 1 1
Pulmonary Emphysema 1 1
Hemoptysis 1 1
Hemorrhage/Bleeding 1 1
Respiratory Distress 1 1
Sepsis 1 1
Myocardial Infarction 1 1
Pulmonary Embolism 1 1
Arrhythmia 1 1
Aspiration/Inhalation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Mar-30-2023
2 Atrium Medical Corporation II Nov-15-2022
3 Atrium Medical Corporation II Nov-25-2021
4 Atrium Medical Corporation II Sep-29-2021
5 DeRoyal Industries Inc II Mar-23-2023
6 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
7 Medline Industries Inc II Oct-22-2019
8 TELEFLEX MEDICAL INC II Aug-03-2020
-
-