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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
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BELLEGROVE MEDICAL SUPPLY, INC.
  SUBSTANTIALLY EQUIVALENT 1
BLUESTONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BRADFORD WRIGHT COMPANIES, INC
  SUBSTANTIALLY EQUIVALENT 1
CIXI LEINUO PLASTIC CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
DANIELS CORPORATION PTY, INC.
  SUBSTANTIALLY EQUIVALENT 1
DANIELS SHARPSMART, INC.
  SUBSTANTIALLY EQUIVALENT 1
GRP & ASSOCIATES
  SUBSTANTIALLY EQUIVALENT 1
HEALTHBEACON LTD
  SUBSTANTIALLY EQUIVALENT 1
HEATHROW SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 1
INDUSTRIAL WATER SOLUTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
INDUSTRIAL WATER SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MARKETING SPECIALISTS INC.
  SUBSTANTIALLY EQUIVALENT 2
MAUZER USA LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL ENGINEERING DEVELOPMENT SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDSOURCE INTERNATIONAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
NINGBO MAXCON MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
NITTA M&T (THAILAND) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NOBLE MARKETING
  SUBSTANTIALLY EQUIVALENT 1
NORTH AMERICAN RESCUE, LLC
  SUBSTANTIALLY EQUIVALENT 1
OAK RIDGE PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 3
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PUREWAY COMPLIANCE INC.
  SUBSTANTIALLY EQUIVALENT 1
PUREWAY COMPLIANCE, INC
  SUBSTANTIALLY EQUIVALENT 1
QLICKSMART PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
REHRIG PACIFIC COMPANY
  SUBSTANTIALLY EQUIVALENT 2
SNYDER INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
STERICYCLE, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRIUMVIRATE ENVIRONMENTAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
WCM WASTE & COMPLIANCE MANAGEMENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 13 13
2015 12 12
2016 27 27
2017 39 39
2018 63 63
2019 56 56
2020 62 62
2021 85 85
2022 38 38
2023 34 34
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Break 75 75
Component Missing 47 47
Crack 40 40
Difficult to Open or Close 37 37
Material Puncture/Hole 32 32
Defective Component 24 24
Device Misassembled During Manufacturing /Shipping 23 23
Device Damaged Prior to Use 20 20
Material Protrusion/Extrusion 19 19
Adverse Event Without Identified Device or Use Problem 10 10
Device Operates Differently Than Expected 8 8
Device Markings/Labelling Problem 8 8
Failure to Cut 7 7
Fail-Safe Problem 7 7
Mechanical Problem 7 7
Improper or Incorrect Procedure or Method 6 6
Fitting Problem 5 5
Out-Of-Box Failure 5 5
Component Incompatible 5 5
Detachment of Device or Device Component 5 5
Material Integrity Problem 5 5
Appropriate Term/Code Not Available 5 5
Component or Accessory Incompatibility 4 4
Connection Problem 4 4
Detachment Of Device Component 4 4
Component Falling 3 3
Leak/Splash 3 3
Use of Device Problem 3 3
Structural Problem 3 3
Defective Device 3 3
Mechanical Jam 3 3
Incomplete or Inadequate Connection 3 3
Insufficient Information 3 3
Packaging Problem 2 2
Protective Measures Problem 2 2
Physical Resistance/Sticking 2 2
Fail-Safe Did Not Operate 2 2
Mechanics Altered 2 2
Nonstandard Device 2 2
Sticking 2 2
Loose or Intermittent Connection 2 2
Hole In Material 2 2
Product Quality Problem 2 2
Difficult to Remove 2 2
Fail-Safe Design Failure 2 2
Unintended Ejection 1 1
Fracture 1 1
Bent 1 1
Retraction Problem 1 1
Device Slipped 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inadequate Storage 1 1
Inaccurate Synchronization 1 1
Device Inoperable 1 1
Unsealed Device Packaging 1 1
Material Perforation 1 1
Device Contamination with Body Fluid 1 1
Overfill 1 1
Device Unsafe to Use in Environment 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Device Tipped Over 1 1
Malposition of Device 1 1
Contamination /Decontamination Problem 1 1
Activation, Positioning or Separation Problem 1 1
Illegible Information 1 1
Separation Problem 1 1
Temperature Problem 1 1
Unintended Movement 1 1
No Apparent Adverse Event 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 147 147
No Known Impact Or Consequence To Patient 74 74
Needle Stick/Puncture 71 71
No Patient Involvement 67 67
No Consequences Or Impact To Patient 57 57
Exposure to Body Fluids 13 13
Insufficient Information 9 9
No Information 9 9
Laceration(s) 2 2
Pain 1 1
Venipuncture 1 1
Injury 1 1
Chemical Exposure 1 1
No Code Available 1 1
Inadequate Osseointegration 1 1
Foreign Body In Patient 1 1
Device Embedded In Tissue or Plaque 1 1

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