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TPLC
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show TPLC since
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Device
container, sharps
Product Code
MMK
Regulation Number
880.5570
Device Class
2
Premarket Reviews
Manufacturer
Decision
BLUESTONE MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
INTERNATIONAL MARKETING SPECIALISTS INC.
SUBSTANTIALLY EQUIVALENT
2
NINGBO MAXCON MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
4
NITTA M&T (THAILAND) CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
PUREWAY COMPLIANCE INC.
SUBSTANTIALLY EQUIVALENT
1
QLICKSMART PTY LTD.
SUBSTANTIALLY EQUIVALENT
1
ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
56
56
2020
62
62
2021
85
85
2022
38
38
2023
34
34
2024
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
64
64
Component Missing
44
44
Difficult to Open or Close
32
32
Device Misassembled During Manufacturing /Shipping
23
23
Crack
21
21
Defective Component
18
18
Device Damaged Prior to Use
17
17
Material Puncture/Hole
9
9
Material Protrusion/Extrusion
9
9
Failure to Cut
7
7
Device Markings/Labelling Problem
6
6
Mechanical Problem
6
6
Component Incompatible
5
5
Fail-Safe Problem
5
5
Component or Accessory Incompatibility
4
4
Leak/Splash
3
3
Fail-Safe Did Not Operate
2
2
Defective Device
2
2
Nonstandard Device
2
2
Loose or Intermittent Connection
2
2
Mechanical Jam
2
2
Physical Resistance/Sticking
2
2
Incomplete or Inadequate Connection
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Detachment of Device or Device Component
2
2
Separation Problem
1
1
Unsealed Device Packaging
1
1
Difficult to Remove
1
1
Inaccurate Synchronization
1
1
Packaging Problem
1
1
Material Deformation
1
1
Protective Measures Problem
1
1
Output Problem
1
1
Material Perforation
1
1
Structural Problem
1
1
Illegible Information
1
1
Product Quality Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
148
148
No Consequences Or Impact To Patient
41
41
No Patient Involvement
37
37
No Known Impact Or Consequence To Patient
36
36
Needle Stick/Puncture
16
16
Insufficient Information
10
10
Exposure to Body Fluids
4
4
No Information
3
3
Inadequate Osseointegration
1
1
Chemical Exposure
1
1
Pain
1
1
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