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TPLC
New Search
show TPLC since
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2019
2020
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2023
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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
118
118
2023
69
69
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
126
126
Leak/Splash
59
59
Suction Problem
36
36
Deformation Due to Compressive Stress
31
31
Device Damaged Prior to Use
26
26
Decrease in Suction
15
15
Complete Blockage
14
14
Unsealed Device Packaging
14
14
Material Twisted/Bent
14
14
Gas/Air Leak
13
13
Tear, Rip or Hole in Device Packaging
12
12
Suction Failure
12
12
Insufficient Information
11
11
Adverse Event Without Identified Device or Use Problem
11
11
Material Deformation
11
11
Component Missing
10
10
Backflow
10
10
Break
10
10
Crack
10
10
Mechanical Problem
8
8
Use of Device Problem
7
7
Air Leak
7
7
Detachment of Device or Device Component
7
7
Material Integrity Problem
6
6
Defective Component
6
6
Off-Label Use
6
6
Appropriate Term/Code Not Available
6
6
Unintended Movement
5
5
Product Quality Problem
5
5
Activation, Positioning or Separation Problem
5
5
Defective Device
4
4
Filling Problem
4
4
Obstruction of Flow
4
4
Improper or Incorrect Procedure or Method
4
4
Delivered as Unsterile Product
4
4
Noise, Audible
4
4
Air/Gas in Device
3
3
Fitting Problem
3
3
Inability to Auto-Fill
3
3
Detachment Of Device Component
3
3
Disconnection
3
3
Connection Problem
3
3
Packaging Problem
3
3
Device Operates Differently Than Expected
3
3
Improper Flow or Infusion
3
3
Infusion or Flow Problem
3
3
Filtration Problem
2
2
Contamination /Decontamination Problem
2
2
Structural Problem
2
2
Degraded
2
2
Collapse
2
2
Material Puncture/Hole
2
2
Device Difficult to Setup or Prepare
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Missing Information
2
2
Material Split, Cut or Torn
2
2
Device Difficult to Maintain
2
2
Device Handling Problem
1
1
Device Fell
1
1
Component Misassembled
1
1
Illegible Information
1
1
Decrease in Pressure
1
1
Loose or Intermittent Connection
1
1
Material Separation
1
1
Increase in Suction
1
1
Inadequate or Insufficient Training
1
1
Contamination
1
1
Burst Container or Vessel
1
1
Material Discolored
1
1
Fracture
1
1
Material Fragmentation
1
1
Labelling, Instructions for Use or Training Problem
1
1
Overfill
1
1
Device Tipped Over
1
1
Malposition of Device
1
1
Patient-Device Incompatibility
1
1
Device Contamination with Chemical or Other Material
1
1
Pressure Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Installation-Related Problem
1
1
Device Dislodged or Dislocated
1
1
Device Markings/Labelling Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
254
254
No Consequences Or Impact To Patient
90
90
No Known Impact Or Consequence To Patient
41
41
Insufficient Information
36
36
Pneumothorax
29
29
No Information
23
23
No Patient Involvement
13
13
Pain
8
8
Unspecified Infection
5
5
Death
5
5
No Code Available
5
5
Pleural Effusion
4
4
Pneumonia
3
3
Dyspnea
3
3
Bacterial Infection
2
2
Low Oxygen Saturation
2
2
Thrombosis
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Weight Changes
1
1
Chronic Obstructive Pulmonary Disease (COPD)
1
1
Post Operative Wound Infection
1
1
Pericardial Effusion
1
1
Aspiration Pneumonitis
1
1
Respiratory Arrest
1
1
Unspecified Respiratory Problem
1
1
Cardiac Arrest
1
1
Cellulitis
1
1
Stroke/CVA
1
1
Chest Pain
1
1
Congestive Heart Failure
1
1
Cyanosis
1
1
Emotional Changes
1
1
Pulmonary Emphysema
1
1
Hemoptysis
1
1
Hemorrhage/Bleeding
1
1
Respiratory Distress
1
1
Sepsis
1
1
Myocardial Infarction
1
1
Pulmonary Embolism
1
1
Arrhythmia
1
1
Aspiration/Inhalation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Atrium Medical Corporation
II
Mar-30-2023
2
Atrium Medical Corporation
II
Nov-15-2022
3
Atrium Medical Corporation
II
Nov-25-2021
4
Atrium Medical Corporation
II
Sep-29-2021
5
DeRoyal Industries Inc
II
Mar-23-2023
6
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
7
Medline Industries Inc
II
Oct-22-2019
8
TELEFLEX MEDICAL INC
II
Aug-03-2020
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