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TPLC
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Device
bottle, collection, vacuum
Regulation Description
Vacuum-powered body fluid suction apparatus.
Product Code
KDQ
Regulation Number
880.6740
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
110
110
2021
110
110
2022
118
118
2023
92
92
2024
167
172
2025
4
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
116
116
Off-Label Use
61
63
Leak/Splash
54
54
Suction Problem
53
53
Complete Blockage
32
32
Deformation Due to Compressive Stress
31
31
Device Damaged Prior to Use
25
25
Use of Device Problem
23
23
Suction Failure
21
21
Decrease in Suction
20
21
Material Deformation
15
15
Material Twisted/Bent
14
14
Insufficient Information
13
13
Unsealed Device Packaging
13
13
Gas/Air Leak
12
13
Crack
11
11
Improper or Incorrect Procedure or Method
9
9
Adverse Event Without Identified Device or Use Problem
8
8
Inadequate or Insufficient Training
7
7
Appropriate Term/Code Not Available
7
7
Disconnection
7
7
Defective Component
6
6
Component Missing
6
6
Material Integrity Problem
6
6
Obstruction of Flow
5
5
Unclear Information
5
5
Activation, Positioning or Separation Problem
5
5
Unexpected Color
5
5
Detachment of Device or Device Component
5
5
Tear, Rip or Hole in Device Packaging
5
5
Unintended Movement
5
5
Product Quality Problem
5
5
Malposition of Device
4
4
Material Discolored
4
4
Mechanical Problem
4
4
Inability to Auto-Fill
3
3
Backflow
3
3
Air/Gas in Device
3
3
Material Split, Cut or Torn
3
3
Fitting Problem
3
3
Connection Problem
3
3
Defective Device
3
3
Material Puncture/Hole
3
3
Packaging Problem
3
3
Material Fragmentation
2
2
Device Difficult to Maintain
2
2
Decrease in Pressure
2
2
Filling Problem
2
2
Infusion or Flow Problem
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
404
409
No Consequences Or Impact To Patient
73
73
Insufficient Information
61
61
Pneumothorax
27
28
Pain
7
7
No Known Impact Or Consequence To Patient
7
7
Hemorrhage/Bleeding
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
No Information
4
4
Distress
3
3
Perforation of Vessels
3
3
No Patient Involvement
3
3
Aspiration/Inhalation
3
3
Death
3
3
Low Oxygen Saturation
2
2
No Code Available
2
2
Bacterial Infection
2
2
Unspecified Infection
2
2
Choking
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
Cardiac Arrest
1
1
Stroke/CVA
1
1
Pulmonary Emphysema
1
1
Hypoxia
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
TELEFLEX MEDICAL INC
II
Aug-03-2020
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