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TPLC
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show TPLC since
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Device
bottle, collection, vacuum
Product Code
KDQ
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
117
117
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
121
121
Leak/Splash
52
52
Deformation Due to Compressive Stress
31
31
Device Damaged Prior to Use
26
26
Suction Problem
18
18
Decrease in Suction
15
15
Unsealed Device Packaging
14
14
Material Twisted/Bent
14
14
Break
12
12
Material Deformation
11
11
Tear, Rip or Hole in Device Packaging
11
11
Suction Failure
11
11
Adverse Event Without Identified Device or Use Problem
10
10
Gas/Air Leak
9
9
Component Missing
9
9
Backflow
9
9
Crack
9
9
Insufficient Information
9
9
Mechanical Problem
8
8
Air Leak
7
7
Detachment of Device or Device Component
7
7
Material Integrity Problem
6
6
Complete Blockage
6
6
Use of Device Problem
6
6
Defective Component
6
6
Activation, Positioning or Separation Problem
5
5
Appropriate Term/Code Not Available
5
5
Noise, Audible
4
4
Obstruction of Flow
4
4
Filling Problem
4
4
Delivered as Unsterile Product
4
4
Detachment Of Device Component
3
3
Defective Device
3
3
Connection Problem
3
3
Packaging Problem
3
3
Improper Flow or Infusion
3
3
Infusion or Flow Problem
3
3
Device Operates Differently Than Expected
3
3
Filtration Problem
2
2
Device Difficult to Maintain
2
2
Structural Problem
2
2
Collapse
2
2
Disconnection
2
2
Degraded
2
2
Improper or Incorrect Procedure or Method
2
2
Device Difficult to Setup or Prepare
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Air/Gas in Device
2
2
Illegible Information
1
1
Missing Information
1
1
Component Misassembled
1
1
Material Split, Cut or Torn
1
1
Device Fell
1
1
Decrease in Pressure
1
1
Off-Label Use
1
1
Product Quality Problem
1
1
Material Separation
1
1
Increase in Suction
1
1
Inadequate or Insufficient Training
1
1
Fitting Problem
1
1
Material Discolored
1
1
Fracture
1
1
Material Fragmentation
1
1
Labelling, Instructions for Use or Training Problem
1
1
Contamination
1
1
Burst Container or Vessel
1
1
Contamination /Decontamination Problem
1
1
Device Markings/Labelling Problem
1
1
Device Tipped Over
1
1
Malposition of Device
1
1
Patient-Device Incompatibility
1
1
Overfill
1
1
No Apparent Adverse Event
1
1
Positioning Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Device Dislodged or Dislocated
1
1
Installation-Related Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
202
202
No Consequences Or Impact To Patient
90
90
No Known Impact Or Consequence To Patient
41
41
Insufficient Information
30
30
Pneumothorax
26
26
No Information
23
23
No Patient Involvement
13
13
Unspecified Infection
5
5
No Code Available
5
5
Death
5
5
Pleural Effusion
4
4
Pneumonia
3
3
Pain
3
3
Dyspnea
3
3
Thrombosis
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Bacterial Infection
2
2
Cellulitis
1
1
Stroke/CVA
1
1
Hemoptysis
1
1
Hemorrhage/Bleeding
1
1
Myocardial Infarction
1
1
Chronic Obstructive Pulmonary Disease (COPD)
1
1
Weight Changes
1
1
Arrhythmia
1
1
Low Oxygen Saturation
1
1
Pulmonary Emphysema
1
1
Pulmonary Embolism
1
1
Cyanosis
1
1
Chest Pain
1
1
Respiratory Distress
1
1
Post Operative Wound Infection
1
1
Congestive Heart Failure
1
1
Emotional Changes
1
1
Sepsis
1
1
Pericardial Effusion
1
1
Unspecified Respiratory Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Atrium Medical Corporation
II
Nov-15-2022
2
Atrium Medical Corporation
II
Nov-25-2021
3
Atrium Medical Corporation
II
Sep-29-2021
4
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
5
Medline Industries Inc
II
Oct-22-2019
6
TELEFLEX MEDICAL INC
II
Aug-03-2020
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