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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
ASAHI POLYSLIDER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BEIJING RUICHENG MEDICAL SUPPLIES CO., LTD.
  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
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 4
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
ROCHE DIABETES CARE, INC.
  SUBSTANTIALLY EQUIVALENT 2
SHANDONG LIANFA MEDICAL PLASTIC PRODUCTS CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
STERILANCE MEDICAL (SUZHOU) INC.
  SUBSTANTIALLY EQUIVALENT 2
SUZHOU KYUAN MEDICAL APPARATUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TASSO, INC.
  SUBSTANTIALLY EQUIVALENT 1
TIANJIN HUAHONG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
TIANJIN RILIFINE MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 534 534
2019 399 399
2020 312 312
2021 245 245
2022 254 254

Device Problems MDRs with this Device Problem Events in those MDRs
Retraction Problem 1221 1221
Physical Property Issue 44 44
Product Quality Problem 41 41
Break 38 38
Delivered as Unsterile Product 37 37
Difficult or Delayed Activation 35 35
Mechanical Problem 34 34
Packaging Problem 28 28
Material Fragmentation 28 28
Device Damaged Prior to Use 25 25
Appropriate Term/Code Not Available 24 24
Device Contamination with Chemical or Other Material 24 24
Material Integrity Problem 24 24
Failure to Align 21 21
Mechanics Altered 21 21
Defective Device 20 20
Defective Component 20 20
Failure to Fire 19 19
Fail-Safe Did Not Operate 14 14
Device Markings/Labelling Problem 14 14
Unable to Obtain Readings 14 14
Misfire 13 13
Material Twisted/Bent 12 12
Protective Measures Problem 11 11
Material Protrusion/Extrusion 11 11
Adverse Event Without Identified Device or Use Problem 11 11
Detachment of Device or Device Component 10 10
Fail-Safe Problem 9 9
Device Operational Issue 8 8
Leak/Splash 7 7
Insufficient Information 7 7
Crack 6 6
Component Missing 6 6
Incorrect Or Inadequate Test Results 5 5
Missing Information 5 5
Complete Blockage 5 5
Material Separation 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Occlusion Within Device 3 3
Loose or Intermittent Connection 3 3
Firing Problem 3 3
Obstruction of Flow 3 3
Incomplete or Missing Packaging 3 3
Infusion or Flow Problem 3 3
Device Operates Differently Than Expected 3 3
Unintended Movement 3 3
Device Contamination with Body Fluid 3 3
Improper or Incorrect Procedure or Method 3 3
Physical Resistance/Sticking 2 2
Material Deformation 2 2
Bent 2 2
Patient-Device Incompatibility 2 2
Device Handling Problem 2 2
Inaccurate Synchronization 2 2
Unsealed Device Packaging 2 2
Device Dislodged or Dislocated 2 2
Device Slipped 2 2
Ejection Problem 2 2
Failure to Eject 2 2
Separation Problem 2 2
Capturing Problem 1 1
Material Split, Cut or Torn 1 1
No Apparent Adverse Event 1 1
Use of Device Problem 1 1
Failure to Deliver 1 1
No Device Output 1 1
Improper Flow or Infusion 1 1
Output Problem 1 1
Failure to Cut 1 1
Sharp Edges 1 1
Premature Separation 1 1
Difficult or Delayed Positioning 1 1
Short Fill 1 1
Volume Accuracy Problem 1 1
Contamination /Decontamination Problem 1 1
Scratched Material 1 1
Device Difficult to Maintain 1 1
Component Incompatible 1 1
Fracture 1 1
Expiration Date Error 1 1
Patient Device Interaction Problem 1 1
Inaccurate Information 1 1
Device Fell 1 1
Incorrect Device Or Component Shipped 1 1
Device Contaminated During Manufacture or Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 798 798
No Clinical Signs, Symptoms or Conditions 377 377
No Known Impact Or Consequence To Patient 313 313
Needle Stick/Puncture 71 71
Hyperglycemia 28 28
Hypoglycemia 21 21
No Patient Involvement 17 17
Device Embedded In Tissue or Plaque 17 17
Anxiety 16 16
Loss of consciousness 16 16
Dizziness 15 15
Pain 14 14
Shaking/Tremors 13 13
No Information 11 11
Headache 10 10
Sweating 9 9
Fatigue 7 7
Discomfort 7 7
Convulsion/Seizure 7 7
No Code Available 6 6
Patient Problem/Medical Problem 6 6
Bruise/Contusion 6 6
Exposure to Body Fluids 6 6
Weakness 5 5
Blurred Vision 5 5
Diaphoresis 5 5
Confusion/ Disorientation 4 4
Swelling/ Edema 4 4
Foreign Body In Patient 4 4
Unspecified Infection 4 4
Insufficient Information 4 4
Laceration(s) 3 3
Vomiting 3 3
Injury 3 3
Local Reaction 3 3
Skin Infection 3 3
Polydipsia 3 3
Hemorrhage/Bleeding 3 3
Inflammation 2 2
Dehydration 2 2
Swelling 2 2
Diabetic Ketoacidosis 2 2
Dysphasia 2 2
Alteration in Body Temperature 2 2
Muscle Weakness 2 2
Rash 2 2
Lethargy 2 2
Unspecified Gastrointestinal Problem 1 1
Contact Dermatitis 1 1
Distress 1 1
Impaired Healing 1 1
Seizures 1 1
Chest Pain 1 1
Syncope 1 1
Vertigo 1 1
Cramp(s) 1 1
Malaise 1 1
Dyspnea 1 1
Fall 1 1
Hypersensitivity/Allergic reaction 1 1
Irritation 1 1
Nausea 1 1
Loss of Vision 1 1
Hot Flashes/Flushes 1 1
Unspecified Tissue Injury 1 1

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