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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device needle, spinal, short term
Regulation Description Anesthesia conduction needle.
Product CodeMIA
Regulation Number 868.5150
Device Class 2

MDR Year MDR Reports MDR Events
2021 4 4
2022 19 19
2023 12 12
2024 23 23
2025 14 14
2026 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 23 23
Leak/Splash 15 15
Adverse Event Without Identified Device or Use Problem 5 5
Product Quality Problem 4 4
Fracture 4 4
Contamination 4 4
Detachment of Device or Device Component 4 4
Device Damaged Prior to Use 3 3
Material Fragmentation 3 3
Crack 2 2
Fluid/Blood Leak 2 2
Device Markings/Labelling Problem 2 2
Material Twisted/Bent 2 2
Mechanical Jam 1 1
Material Separation 1 1
Illegible Information 1 1
Wrong Label 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Defective Component 1 1
Failure to Deliver 1 1
Connection Problem 1 1
Device Difficult to Setup or Prepare 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 43 43
Foreign Body In Patient 22 22
Numbness 4 4
Insufficient Information 4 4
Unspecified Tissue Injury 4 4
Pain 3 3
Unspecified Infection 1 1
Paresthesia 1 1
Needle Stick/Puncture 1 1
Distress 1 1
Device Embedded In Tissue or Plaque 1 1

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