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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
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 125 125
Off-Label Use 56 56
Leak/Splash 54 54
Suction Problem 47 47
Complete Blockage 32 32
Deformation Due to Compressive Stress 31 31
Device Damaged Prior to Use 25 25
Decrease in Suction 23 23
Suction Failure 20 20
Use of Device Problem 19 19
Material Deformation 15 15
Material Twisted/Bent 15 15
Unsealed Device Packaging 14 14
Gas/Air Leak 13 13
Component Missing 13 13
Tear, Rip or Hole in Device Packaging 12 12
Crack 11 11
Break 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Appropriate Term/Code Not Available 8 8
Insufficient Information 8 8
Disconnection 7 7
Inadequate or Insufficient Training 7 7
Mechanical Problem 7 7
Detachment of Device or Device Component 7 7
Defective Component 6 6
Material Integrity Problem 6 6
Obstruction of Flow 6 6
Activation, Positioning or Separation Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Product Quality Problem 5 5
Filling Problem 5 5
Unintended Movement 5 5
Unclear Information 5 5
Noise, Audible 4 4
Unexpected Color 4 4
Delivered as Unsterile Product 4 4
Material Discolored 4 4
Fitting Problem 4 4
Defective Device 4 4
Backflow 3 3
Air/Gas in Device 3 3
Inability to Auto-Fill 3 3
Infusion or Flow Problem 3 3
Connection Problem 3 3
Packaging Problem 3 3
Material Puncture/Hole 3 3
Material Split, Cut or Torn 3 3
Material Fragmentation 2 2
Degraded 2 2

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 85 85
Insufficient Information 53 53
No Known Impact Or Consequence To Patient 35 35
Pneumothorax 27 27
No Information 9 9
No Patient Involvement 8 8
Pain 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Death 3 3
No Code Available 3 3
Aspiration/Inhalation 3 3
Distress 3 3
Unspecified Infection 2 2
Bacterial Infection 2 2
Low Oxygen Saturation 2 2
Cyanosis 1 1
Stroke/CVA 1 1
Respiratory Arrest 1 1
Pulmonary Emphysema 1 1
Cardiac Arrest 1 1
Unspecified Blood or Lymphatic problem 1 1
Vomiting 1 1
Dyspnea 1 1
Laceration(s) 1 1
Pneumonia 1 1
Hypoxia 1 1
Unspecified Respiratory Problem 1 1
Respiratory Insufficiency 1 1
Aspiration Pneumonitis 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 Medline Industries Inc II Oct-22-2019
11 TELEFLEX MEDICAL INC II Aug-03-2020
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