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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device single use only blood lancet with an integral sharps injury prevention feature
Definition A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.
Product CodeFMK
Regulation Number 878.4850
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCRIVA DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASAHI POLYSLIDER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BEIJING RUICHENG MEDICAL SUPPLIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CLINICAL INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DRAWBRIDGE HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
FACET TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
GRI-ALLESET, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEBEI XINLE SCI&TECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HTL-STREFA S.A.
  SUBSTANTIALLY EQUIVALENT 1
HUAIAN HENING MEDICAL INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MEDIPURPOSE PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO MEDSUN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NSP TECH PTE LTD
  SUBSTANTIALLY EQUIVALENT 2
OWEN MUMFORD LTD
  SUBSTANTIALLY EQUIVALENT 5
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
REDDROP DX
  SE - WITH LIMITATIONS 1
ROCHE DIABETES CARE, INC.
  SUBSTANTIALLY EQUIVALENT 4
SARSTEDT AG & CO KG
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG LIANFA MEDICAL PLASTIC PRODUCTS CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
STERILANCE MEDICAL (SUZHOU) INC.
  SUBSTANTIALLY EQUIVALENT 3
SUZHOU KYUAN MEDICAL APPARATUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU ZHENWU MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TASSO, INC.
  SUBSTANTIALLY EQUIVALENT 1
TIANJIN HUAHONG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
TIANJIN RILIFINE MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YOURBIO HEALTH, INC.
  SE - WITH LIMITATIONS 1

MDR Year MDR Reports MDR Events
2019 399 399
2020 312 312
2021 245 245
2022 254 254
2023 283 283
2024 127 127

Device Problems MDRs with this Device Problem Events in those MDRs
Retraction Problem 1173 1173
Product Quality Problem 38 38
Delivered as Unsterile Product 33 33
Defective Device 30 30
Device Contamination with Chemical or Other Material 28 28
Difficult or Delayed Activation 24 24
Material Fragmentation 23 23
Device Damaged Prior to Use 22 22
Packaging Problem 22 22
Appropriate Term/Code Not Available 21 21
Defective Component 21 21
Break 21 21
Failure to Fire 20 20
Device Markings/Labelling Problem 20 20
Detachment of Device or Device Component 15 15
Unable to Obtain Readings 15 15
Material Twisted/Bent 13 13
Material Protrusion/Extrusion 12 12
Component Missing 11 11
Fail-Safe Did Not Operate 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Protective Measures Problem 8 8
Material Separation 8 8
Insufficient Information 8 8
Mechanical Problem 7 7
Misfire 7 7
Separation Problem 6 6
Missing Information 6 6
Fail-Safe Problem 5 5
Material Deformation 5 5
Crack 5 5
Firing Problem 4 4
Physical Resistance/Sticking 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Leak/Splash 3 3
Improper or Incorrect Procedure or Method 3 3
Incomplete or Missing Packaging 3 3
Device Contamination with Body Fluid 3 3
Separation Failure 2 2
Loose or Intermittent Connection 2 2
Inaccurate Synchronization 2 2
Mechanical Jam 2 2
Material Integrity Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Contamination /Decontamination Problem 2 2
Activation, Positioning or Separation Problem 2 2
Sharp Edges 2 2
Premature Separation 2 2
Ejection Problem 2 2
Failure to Eject 2 2
Unintended Movement 2 2
Device Difficult to Maintain 1 1
No Apparent Adverse Event 1 1
Patient Device Interaction Problem 1 1
Material Split, Cut or Torn 1 1
Scratched Material 1 1
Output Problem 1 1
Device Fell 1 1
Device Dislodged or Dislocated 1 1
Improper Flow or Infusion 1 1
Use of Device Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Short Fill 1 1
Device Slipped 1 1
Difficult or Delayed Positioning 1 1
Complete Blockage 1 1
Insufficient Flow or Under Infusion 1 1
Patient-Device Incompatibility 1 1
Capturing Problem 1 1
Solder Joint Fracture 1 1
Failure to Deliver 1 1
Expiration Date Error 1 1
Illegible Information 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 746 746
No Consequences Or Impact To Patient 523 523
No Known Impact Or Consequence To Patient 128 128
Needle Stick/Puncture 60 60
Hypoglycemia 25 25
Hyperglycemia 21 21
Loss of consciousness 18 18
No Patient Involvement 17 17
Dizziness 14 14
Pain 12 12
Shaking/Tremors 12 12
Device Embedded In Tissue or Plaque 12 12
Insufficient Information 12 12
Headache 10 10
Fatigue 9 9
Anxiety 8 8
Sweating 7 7
No Information 7 7
Convulsion/Seizure 7 7
Exposure to Body Fluids 6 6
Diaphoresis 5 5
Weakness 4 4
Laceration(s) 4 4
Skin Infection 4 4
Swelling/ Edema 4 4
Unspecified Tissue Injury 3 3
Foreign Body In Patient 3 3
Patient Problem/Medical Problem 3 3
Confusion/ Disorientation 3 3
Blurred Vision 3 3
Discomfort 3 3
Bruise/Contusion 3 3
Unspecified Infection 3 3
Inflammation 2 2
Rash 2 2
Local Reaction 2 2
Impaired Healing 2 2
Muscle Weakness 2 2
Dysphasia 2 2
Lethargy 2 2
No Code Available 2 2
Alteration in Body Temperature 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Polydipsia 1 1
Unspecified Gastrointestinal Problem 1 1
Injection Site Reaction 1 1
Skin Inflammation/ Irritation 1 1
Contact Dermatitis 1 1
Hot Flashes/Flushes 1 1
Cramp(s) 1 1
Nerve Damage 1 1
Loss of Vision 1 1
Vomiting 1 1
Injury 1 1
Malaise 1 1
Diabetic Ketoacidosis 1 1
Swelling 1 1
Vertigo 1 1
Irritation 1 1
Chest Pain 1 1
Dyspnea 1 1
Fall 1 1
Syncope 1 1
Hepatitis 1 1

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