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TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
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Device
bottle, collection, vacuum
Product Code
KDQ
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
Air Leak
21
21
Use of Device Problem
21
21
Suction Failure
20
20
Adverse Event Without Identified Device or Use Problem
17
17
Material Deformation
17
17
Unsealed Device Packaging
16
16
Component Missing
16
16
Insufficient Information
16
16
Material Twisted/Bent
15
15
Burst Container or Vessel
14
14
Tear, Rip or Hole in Device Packaging
14
14
Gas/Air Leak
13
13
Appropriate Term/Code Not Available
12
12
Disconnection
12
12
Material Separation
11
11
Collapse
11
11
Material Integrity Problem
11
11
Detachment of Device or Device Component
10
10
Backflow
10
10
Connection Problem
10
10
Mechanical Problem
9
9
Loose or Intermittent Connection
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
Filling Problem
6
6
Noise, Audible
6
6
Defective Component
6
6
Product Quality Problem
5
5
Fracture
5
5
Contamination
5
5
Activation, Positioning or Separation Problem
5
5
Unintended Movement
5
5
Unclear Information
5
5
Defective Device
4
4
Device Slipped
4
4
Malposition of Device
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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