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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lancet, blood
Regulation Description Manual surgical instrument for general use.
Product CodeFMK
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
GENTEEL, LLC
  SUBSTANTIALLY EQUIVALENT 1
GRI MEDICAL & ELECTRONIC TECHNOLOGY CO, LTD
  SUBSTANTIALLY EQUIVALENT 1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
STERILANCE MEDICAL (SUZHOU) INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 539 539
2017 531 531
2018 534 534
2019 399 399
2020 312 312
2021 168 168

Device Problems MDRs with this Device Problem Events in those MDRs
Retraction Problem 1942 1942
Break 44 44
Physical Property Issue 44 44
Delivered as Unsterile Product 38 38
Product Quality Problem 34 34
Material Fragmentation 34 34
Mechanical Problem 34 34
Difficult or Delayed Activation 33 33
Packaging Problem 26 26
Material Integrity Problem 24 24
Device Damaged Prior to Use 23 23
Mechanics Altered 22 22
Device Contamination with Chemical or Other Material 22 22
Failure to Align 21 21
Material Protrusion/Extrusion 20 20
Appropriate Term/Code Not Available 18 18
Defective Device 17 17
Device Operates Differently Than Expected 17 17
Adverse Event Without Identified Device or Use Problem 16 16
Device Markings/Labelling Problem 15 15
Misfire 14 14
Failure to Fire 13 13
Defective Component 13 13
Insufficient Information 12 12
Fail-Safe Did Not Operate 10 10
Fail-Safe Problem 9 9
Protective Measures Problem 9 9
Component Missing 9 9
Device Operational Issue 8 8
Material Separation 8 8
Incorrect Or Inadequate Test Results 8 8
Detachment of Device or Device Component 8 8
Material Twisted/Bent 7 7
Leak/Splash 7 7
Detachment Of Device Component 6 6
Unable to Obtain Readings 6 6
Improper or Incorrect Procedure or Method 5 5
Complete Blockage 5 5
Crack 5 5
Bent 4 4
Incorrect, Inadequate or Imprecise Resultor Readings 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Unintended Movement 4 4
Occlusion Within Device 3 3
Device Contamination with Body Fluid 3 3
Device Inoperable 3 3
Loose or Intermittent Connection 3 3
Use of Device Problem 3 3
Obstruction of Flow 3 3
Incomplete or Missing Packaging 3 3
Infusion or Flow Problem 3 3
Failure to Eject 2 2
Device Handling Problem 2 2
Out-Of-Box Failure 2 2
Unsealed Device Packaging 2 2
Device Slipped 2 2
Inaccurate Synchronization 2 2
Melted 2 2
Fail-Safe Design Failure 2 2
Scratched Material 2 2
Material Deformation 2 2
Incorrect Device Or Component Shipped 1 1
Device Contamination With Biological Material 1 1
Device Fell 1 1
Missing Information 1 1
Failure to Advance 1 1
Difficult or Delayed Positioning 1 1
Entrapment of Device 1 1
Volume Accuracy Problem 1 1
No Device Output 1 1
Disassembly 1 1
Fracture 1 1
Component Incompatible 1 1
Premature Activation 1 1
Material Puncture/Hole 1 1
Failure to Deliver 1 1
Expiration Date Error 1 1
Split 1 1
Failure to Cut 1 1
Patient-Device Incompatibility 1 1
Device Dislodged or Dislocated 1 1
Expulsion 1 1
Patient Device Interaction Problem 1 1
Ejection Problem 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1531 1531
No Known Impact Or Consequence To Patient 580 580
Needle Stick/Puncture 100 100
No Clinical Signs, Symptoms or Conditions 91 91
Hyperglycemia 28 28
No Patient Involvement 20 20
Device Embedded In Tissue or Plaque 17 17
Pain 17 17
Anxiety 17 17
Hypoglycemia 16 16
Exposure to Body Fluids 15 15
Discomfort 13 13
No Information 12 12
Dizziness 11 11
Loss of consciousness 11 11
Shaking/Tremors 10 10
Headache 9 9
Sweating 9 9
Injury 8 8
Foreign Body In Patient 7 7
Patient Problem/Medical Problem 6 6
No Code Available 6 6
Bruise/Contusion 6 6
Unspecified Infection 6 6
Fatigue 6 6
Hemorrhage/Bleeding 5 5
Blurred Vision 5 5
Confusion/ Disorientation 5 5
Weakness 5 5
Vomiting 4 4
Distress 4 4
Diaphoresis 4 4
Swelling 4 4
Inflammation 3 3
Local Reaction 3 3
Seizures 2 2
Laceration(s) 2 2
Dysphasia 2 2
Polydipsia 2 2
Diabetic Ketoacidosis 2 2
Alteration in Body Temperature 2 2
Muscle Weakness 2 2
Dehydration 2 2
Lethargy 2 2
Insufficient Information 2 2
Convulsion/Seizure 2 2
Contact Dermatitis 1 1
Malaise 1 1
Numbness 1 1
Dyspnea 1 1
Fall 1 1
Hypersensitivity/Allergic reaction 1 1
Vessel Or Plaque, Device Embedded In 1 1
Irritation 1 1
Vertigo 1 1
Chills 1 1
Cramp(s) 1 1
Palpitations 1 1
Swelling/ Edema 1 1
Nerve Proximity Nos (Not Otherwise Specified) 1 1
Impaired Healing 1 1
Sore Throat 1 1
Syncope 1 1
Hot Flashes/Flushes 1 1
Nausea 1 1
Chest Pain 1 1
Bronchitis 1 1
Urinary Tract Infection 1 1
Loss of Vision 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health Inc. II Jun-23-2021
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