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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device needle, interosseous
Product CodeMHC
Regulation Number 880.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
BARD ACCESS SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 5 5
Loose or Intermittent Connection 1 1
Detachment of Device or Device Component 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
No Patient Involvement 1 1

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