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TPLC
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show TPLC since
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Device
container, liquid medication, graduated
Regulation Description
Liquid medication dispenser.
Product Code
KYW
Regulation Number
880.6430
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
24
24
2021
15
15
2022
35
35
2023
19
19
2024
13
13
2025
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Contamination with Chemical or Other Material
24
24
Device Markings/Labelling Problem
11
11
Leak/Splash
10
10
Patient Device Interaction Problem
9
9
Fluid/Blood Leak
9
9
Volume Accuracy Problem
8
8
Physical Resistance/Sticking
4
4
Defective Component
3
3
Failure to Deliver
2
2
Delivered as Unsterile Product
2
2
Packaging Problem
2
2
Disconnection
1
1
Break
1
1
Complete Blockage
1
1
Patient-Device Incompatibility
1
1
Expiration Date Error
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Contamination
1
1
Difficult to Remove
1
1
Contamination /Decontamination Problem
1
1
Shipping Damage or Problem
1
1
Obstruction of Flow
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Sharp Edges
1
1
Material Deformation
1
1
Labelling, Instructions for Use or Training Problem
1
1
Product Quality Problem
1
1
Illegible Information
1
1
Missing Information
1
1
Fungus in Device Environment
1
1
Loose or Intermittent Connection
1
1
Mechanical Jam
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
71
71
No Known Impact Or Consequence To Patient
10
10
No Patient Involvement
9
9
Pulmonary Emphysema
5
5
No Consequences Or Impact To Patient
5
5
Insufficient Information
3
3
Pneumonia
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Pneumothorax
1
1
Aspiration/Inhalation
1
1
Reaction to Medicinal Component of Device
1
1
Dyspnea
1
1
Airway Obstruction
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Centurion Medical Products Corporation
II
Feb-05-2020
2
Medicina Uk Ltd
II
Oct-20-2022
3
Sol-Millennium Medical Inc.
II
Sep-06-2024
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