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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
Regulation Description Vacuum-powered body fluid suction apparatus.
Product CodeKDQ
Regulation Number 880.6740
Device Class 2

MDR Year MDR Reports MDR Events
2020 110 110
2021 110 110
2022 118 118
2023 92 92
2024 167 172
2025 4 8

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 116 116
Off-Label Use 61 63
Leak/Splash 54 54
Suction Problem 53 53
Complete Blockage 32 32
Deformation Due to Compressive Stress 31 31
Device Damaged Prior to Use 25 25
Use of Device Problem 23 23
Suction Failure 21 21
Decrease in Suction 20 21
Material Deformation 15 15
Material Twisted/Bent 14 14
Insufficient Information 13 13
Unsealed Device Packaging 13 13
Gas/Air Leak 12 13
Crack 11 11
Improper or Incorrect Procedure or Method 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Inadequate or Insufficient Training 7 7
Appropriate Term/Code Not Available 7 7
Disconnection 7 7
Defective Component 6 6
Component Missing 6 6
Material Integrity Problem 6 6
Obstruction of Flow 5 5
Unclear Information 5 5
Activation, Positioning or Separation Problem 5 5
Unexpected Color 5 5
Detachment of Device or Device Component 5 5
Tear, Rip or Hole in Device Packaging 5 5
Unintended Movement 5 5
Product Quality Problem 5 5
Malposition of Device 4 4
Material Discolored 4 4
Mechanical Problem 4 4
Inability to Auto-Fill 3 3
Backflow 3 3
Air/Gas in Device 3 3
Material Split, Cut or Torn 3 3
Fitting Problem 3 3
Connection Problem 3 3
Defective Device 3 3
Material Puncture/Hole 3 3
Packaging Problem 3 3
Material Fragmentation 2 2
Device Difficult to Maintain 2 2
Decrease in Pressure 2 2
Filling Problem 2 2
Infusion or Flow Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 404 409
No Consequences Or Impact To Patient 73 73
Insufficient Information 61 61
Pneumothorax 27 28
Pain 7 7
No Known Impact Or Consequence To Patient 7 7
Hemorrhage/Bleeding 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
No Information 4 4
Distress 3 3
Perforation of Vessels 3 3
No Patient Involvement 3 3
Aspiration/Inhalation 3 3
Death 3 3
Low Oxygen Saturation 2 2
No Code Available 2 2
Bacterial Infection 2 2
Unspecified Infection 2 2
Choking 1 1
Laceration(s) 1 1
Pneumonia 1 1
Vomiting 1 1
Great Vessel Perforation 1 1
Unspecified Blood or Lymphatic problem 1 1
Aspiration Pneumonitis 1 1
Bronchial Hemorrhage 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 1 1
Unspecified Respiratory Problem 1 1
Cardiac Arrest 1 1
Stroke/CVA 1 1
Pulmonary Emphysema 1 1
Hypoxia 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 DeRoyal Industries Inc II Mar-23-2023
7 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
9 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
10 TELEFLEX MEDICAL INC II Aug-03-2020
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