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TPLC
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show TPLC since
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2024
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Device
container, liquid medication, graduated
Product Code
KYW
Regulation Number
880.6430
Device Class
1
MDR Year
MDR Reports
MDR Events
2015
1
1
2016
1
1
2017
3
3
2018
23
23
2019
38
38
2020
24
24
2021
15
15
2022
35
35
2023
19
19
2024
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Contamination with Chemical or Other Material
40
40
Device Markings/Labelling Problem
31
31
Fluid/Blood Leak
11
11
Volume Accuracy Problem
10
10
Leak/Splash
10
10
Patient Device Interaction Problem
9
9
Break
6
6
Physical Resistance/Sticking
5
5
Packaging Problem
3
3
Contamination /Decontamination Problem
3
3
Illegible Information
3
3
Loose or Intermittent Connection
3
3
Defective Component
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Delivered as Unsterile Product
2
2
Material Deformation
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Device Packaging Compromised
2
2
Failure to Deliver
2
2
Appropriate Term/Code Not Available
2
2
Sharp Edges
1
1
Moisture Damage
1
1
Contamination
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Material Integrity Problem
1
1
Expiration Date Error
1
1
Unsealed Device Packaging
1
1
Material Disintegration
1
1
Complete Blockage
1
1
Patient-Device Incompatibility
1
1
Disconnection
1
1
Mechanical Jam
1
1
Human-Device Interface Problem
1
1
Fungus in Device Environment
1
1
Sticking
1
1
Missing Information
1
1
Product Quality Problem
1
1
Contamination of Device Ingredient or Reagent
1
1
Device Disinfection Or Sterilization Issue
1
1
Material Discolored
1
1
Obstruction of Flow
1
1
Component Missing
1
1
Shipping Damage or Problem
1
1
Crack
1
1
Split
1
1
Device Damaged Prior to Use
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
67
67
No Known Impact Or Consequence To Patient
60
60
No Patient Involvement
15
15
No Consequences Or Impact To Patient
9
9
Pulmonary Emphysema
5
5
No Information
3
3
Insufficient Information
3
3
Pneumonia
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Pneumothorax
1
1
No Code Available
1
1
Aspiration/Inhalation
1
1
Reaction to Medicinal Component of Device
1
1
Overdose
1
1
Foreign Body In Patient
1
1
Choking
1
1
Dyspnea
1
1
Underdose
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
Medline Industries Inc
II
Aug-11-2016
4
Sol-Millennium Medical Inc.
II
Sep-06-2024
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