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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device needle, emergency airway
Regulation Description Emergency airway needle.
Product CodeBWC
Regulation Number 868.5090
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 1
2022 4 4
2024 1 1
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Markings/Labelling Problem 2 2
Device Contaminated During Manufacture or Shipping 1 1
Break 1 1
Patient-Device Incompatibility 1 1
Insufficient Information 1 1
Unclear Information 1 1
Component Missing 1 1
Failure to Advance 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Insufficient Information 2 2
Cardiac Arrest 1 1
Foreign Body In Patient 1 1
Respiratory Insufficiency 1 1
Low Oxygen Saturation 1 1

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