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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, nasal, oxygen
Product CodeBZB
Regulation Number 868.5350
Device Class 1

MDR Year MDR Reports MDR Events
2014 13 13
2015 6 6
2018 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 8 8
Inflation Problem 5 5
Sparking 2 2
Flare or Flash 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Electrical /Electronic Property Problem 2 2
Packaging Problem 1 1
Device Packaging Compromised 1 1
Kinked 1 1
Occlusion Within Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 13 13
No Patient Involvement 3 3
Burn(s) 2 2
Irritation 2 2
Itching Sensation 1 1
Swelling 1 1
Erythema 1 1

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