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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
2019
57
57
2020
110
110
2021
110
110
2022
118
118
2023
92
92
2024
153
155
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
125
125
Off-Label Use
59
61
Leak/Splash
54
54
Suction Problem
50
50
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
21
21
Use of Device Problem
21
21
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
Insufficient Information
12
12
Crack
11
11
Adverse Event Without Identified Device or Use Problem
10
10
Improper or Incorrect Procedure or Method
9
9
Break
9
9
Appropriate Term/Code Not Available
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
Malposition of Device
5
5
Product Quality Problem
5
5
Filling Problem
5
5
Unexpected Color
5
5
Unintended Movement
5
5
Unclear Information
5
5
Noise, Audible
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
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
393
395
No Consequences Or Impact To Patient
85
85
Insufficient Information
58
58
No Known Impact Or Consequence To Patient
35
35
Pneumothorax
30
30
No Information
9
9
No Patient Involvement
8
8
Pain
7
7
Hemorrhage/Bleeding
5
5
Death
3
3
Aspiration/Inhalation
3
3
Perforation of Vessels
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Distress
3
3
No Code Available
3
3
Low Oxygen Saturation
2
2
Unspecified Infection
2
2
Bacterial Infection
2
2
Cardiac Arrest
1
1
Stroke/CVA
1
1
Cyanosis
1
1
Dyspnea
1
1
Pulmonary Emphysema
1
1
Hypoxia
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
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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