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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device container, sharps
Product CodeMMK
Regulation Number 880.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
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
Mechanical Problem 6 6
Device Markings/Labelling Problem 6 6
Fail-Safe Problem 5 5
Component Incompatible 5 5
Component or Accessory Incompatibility 4 4
Leak/Splash 3 3
Physical Resistance/Sticking 2 2
Incomplete or Inadequate Connection 2 2
Fail-Safe Did Not Operate 2 2
Defective Device 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Detachment of Device or Device Component 2 2
Nonstandard Device 2 2
Loose or Intermittent Connection 2 2
Mechanical Jam 2 2
Separation Problem 1 1
Output Problem 1 1
Unsealed Device Packaging 1 1
Difficult to Remove 1 1
Inaccurate Synchronization 1 1
Material Perforation 1 1
Structural Problem 1 1
Material Deformation 1 1
Packaging Problem 1 1
Product Quality Problem 1 1
Illegible Information 1 1
Protective Measures 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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