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TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
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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
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
Mechanical Problem
7
7
Detachment of Device or Device Component
7
7
Inadequate or Insufficient Training
7
7
Disconnection
7
7
Material Integrity Problem
6
6
Defective Component
6
6
Obstruction of Flow
6
6
Improper or Incorrect Procedure or Method
5
5
Product Quality Problem
5
5
Unclear Information
5
5
Unintended Movement
5
5
Filling Problem
5
5
Activation, Positioning or Separation Problem
5
5
Defective Device
4
4
Material Discolored
4
4
Noise, Audible
4
4
Delivered as Unsterile Product
4
4
Fitting Problem
4
4
Unexpected Color
4
4
Material Puncture/Hole
3
3
Connection Problem
3
3
Material Split, Cut or Torn
3
3
Packaging Problem
3
3
Infusion or Flow Problem
3
3
Inability to Auto-Fill
3
3
Air/Gas in Device
3
3
Backflow
3
3
Melted
2
2
Contamination /Decontamination Problem
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
Unspecified Respiratory Problem
1
1
Hypoxia
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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