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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device container, sharps
Regulation Description Hypodermic single lumen needle.
Product CodeMMK
Regulation Number 880.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
BLUESTONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEALTHBEACON LTD
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MARKETING SPECIALISTS INC.
  SUBSTANTIALLY EQUIVALENT 2
MAUZER USA LLC
  SUBSTANTIALLY EQUIVALENT 1
NINGBO MAXCON MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
NITTA M&T (THAILAND) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 39 39
2018 63 63
2019 56 56
2020 62 62
2021 84 84

Device Problems MDRs with this Device Problem Events in those MDRs
Break 56 56
Crack 34 34
Component Missing 34 34
Difficult to Open or Close 22 22
Device Misassembled During Manufacturing /Shipping 20 20
Material Puncture/Hole 17 17
Device Damaged Prior to Use 16 16
Defective Component 14 14
Material Protrusion/Extrusion 12 12
Fail-Safe Problem 7 7
Device Markings/Labelling Problem 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Fitting Problem 5 5
Detachment of Device or Device Component 5 5
Failure to Cut 5 5
Component or Accessory Incompatibility 4 4
Connection Problem 4 4
Component Incompatible 4 4
Appropriate Term/Code Not Available 4 4
Incomplete or Inadequate Connection 3 3
Mechanical Jam 3 3
Material Integrity Problem 3 3
Detachment Of Device Component 3 3
Hole In Material 2 2
Leak/Splash 2 2
Mechanical Problem 2 2
Nonstandard Device 2 2
Difficult to Remove 2 2
Defective Device 2 2
Structural Problem 2 2
Device Operates Differently Than Expected 2 2
Physical Resistance/Sticking 2 2
Protective Measures Problem 2 2
No Apparent Adverse Event 1 1
Separation Problem 1 1
Fail-Safe Did Not Operate 1 1
Illegible Information 1 1
Material Deformation 1 1
Mechanics Altered 1 1
Packaging Problem 1 1
Device Unsafe to Use in Environment 1 1
Activation, Positioning or SeparationProblem 1 1
Product Quality Problem 1 1
Out-Of-Box Failure 1 1
Overfill 1 1
Device Slipped 1 1
Inadequate Storage 1 1
Inaccurate Synchronization 1 1
Improper or Incorrect Procedure or Method 1 1
Loose or Intermittent Connection 1 1
Labelling, Instructions for Use or Training Problem 1 1
Component Falling 1 1
Fail-Safe Design Failure 1 1
Unintended Ejection 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 74 74
No Known Impact Or Consequence To Patient 65 65
No Patient Involvement 62 62
No Consequences Or Impact To Patient 56 56
Needle Stick/Puncture 33 33
Exposure to Body Fluids 9 9
No Information 8 8
Insufficient Information 6 6
No Code Available 1 1
Laceration(s) 1 1
Pain 1 1
Injury 1 1
Chemical Exposure 1 1
Inadequate Osseointegration 1 1

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