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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
Regulation Description Blood lancets.
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 2
HEBEI XINLE SCI&TECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HLB CO., LTD. HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
HTL-STREFA S.A.
  SUBSTANTIALLY EQUIVALENT 1
HUAIAN HENING MEDICAL INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MEDIFUN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDIPURPOSE PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO CAREMED MEDICAL PRODUCTS CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO MEDSUN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
NSP TECH PTE LTD
  SUBSTANTIALLY EQUIVALENT 2
OWEN MUMFORD LTD
  SUBSTANTIALLY EQUIVALENT 5
PRIVAPATH DIAGNOSTICS LTD (DBA LETSGETCHECKED)
  SE - WITH LIMITATIONS 1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 4
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
2020 312 312
2021 245 245
2022 254 254
2023 282 282
2024 243 243
2025 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Retraction Problem 1017 1017
Product Quality Problem 27 27
Device Contamination with Chemical or Other Material 26 26
Defective Device 21 21
Break 20 20
Material Fragmentation 20 20
Failure to Fire 19 19
Defective Component 19 19
Device Markings/Labelling Problem 18 18
Delivered as Unsterile Product 18 18
Appropriate Term/Code Not Available 17 17
Detachment of Device or Device Component 16 16
Unable to Obtain Readings 15 15
Difficult or Delayed Activation 14 14
Material Twisted/Bent 13 13
Packaging Problem 11 11
Material Separation 10 10
Component Missing 10 10
Insufficient Information 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Material Protrusion/Extrusion 7 7
Separation Problem 6 6
Mechanical Problem 6 6
Missing Information 6 6
Fail-Safe Did Not Operate 6 6
Material Deformation 5 5
Firing Problem 4 4
Device Damaged Prior to Use 4 4
Premature Separation 3 3
Device Contamination with Body Fluid 3 3
Protective Measures Problem 3 3
Physical Resistance/Sticking 3 3
Crack 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Ejection Problem 3 3
Mechanical Jam 2 2
Improper or Incorrect Procedure or Method 2 2
Loose or Intermittent Connection 2 2
Sharp Edges 2 2
Misfire 2 2
Contamination /Decontamination Problem 2 2
Material Integrity Problem 2 2
Separation Failure 2 2
Failure to Eject 2 2
Device Contaminated During Manufacture or Shipping 2 2
Activation, Positioning or Separation Problem 2 2
Improper Flow or Infusion 1 1
Inaccurate Synchronization 1 1
Device Difficult to Maintain 1 1
Insufficient Flow or Under Infusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 880 880
No Consequences Or Impact To Patient 268 268
Needle Stick/Puncture 49 49
No Known Impact Or Consequence To Patient 34 34
Hypoglycemia 21 21
Loss of consciousness 18 18
No Patient Involvement 16 16
Insufficient Information 15 15
Hyperglycemia 13 13
Dizziness 10 10
Shaking/Tremors 9 9
Device Embedded In Tissue or Plaque 8 8
Pain 8 8
Headache 7 7
Convulsion/Seizure 7 7
Fatigue 6 6
Skin Infection 5 5
Diaphoresis 5 5
Laceration(s) 5 5
Exposure to Body Fluids 5 5
Swelling/ Edema 4 4
Sweating 4 4
Foreign Body In Patient 4 4
Unspecified Tissue Injury 3 3
No Information 3 3
Unspecified Infection 3 3
Rash 2 2
Confusion/ Disorientation 2 2
Alteration in Body Temperature 2 2
Local Reaction 2 2
Muscle Weakness 2 2
Anxiety 2 2
Syncope/Fainting 2 2
Dysphasia 2 2
Hepatitis 1 1
Irritation 1 1
Weakness 1 1
Injury 1 1
Abrasion 1 1
Nerve Damage 1 1
Inflammation 1 1
Skin Inflammation/ Irritation 1 1
Dyspnea 1 1
Fall 1 1
Diabetic Ketoacidosis 1 1
Unspecified Gastrointestinal Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Polydipsia 1 1
Contact Dermatitis 1 1
Injection Site Reaction 1 1

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