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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 without 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, nonreusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.
Product CodeQRK
Regulation Number 878.4850
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSUNGMEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FACET TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
HUAIAN HENING MEDICAL INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MEDIPOINT HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NINGBO MEDSUN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SEWON MEDICAL CO.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI CARELIFE INTERNATIONAL TRADING CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
STAT MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 3
STERILANCE MEDICAL (SUZHOU) INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 2 2
2023 12 12
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 9 9
Product Quality Problem 4 4
Dull, Blunt 2 2
Insufficient Information 2 2
Material Fragmentation 1 1
Defective Device 1 1
Detachment of Device or Device Component 1 1
Retraction Problem 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
Bruise/Contusion 3 3
Hemorrhage/Bleeding 2 2
Unspecified Infection 2 2
Pain 1 1
Needle Stick/Puncture 1 1
Foreign Body In Patient 1 1
Ecchymosis 1 1

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