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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tube, aspirating, flexible, connecting
Product CodeBYY
Regulation Number 880.6740
Device Class 2

MDR Year MDR Reports MDR Events
2019 18 18
2020 23 23
2021 11 11
2022 11 11
2023 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 65 65
Detachment of Device or Device Component 2 2
Device Contamination with Chemical or Other Material 2 2
Physical Resistance/Sticking 1 1
Suction Failure 1 1
Component Missing 1 1
Break 1 1
Contamination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 37 37
No Patient Involvement 31 31
No Consequences Or Impact To Patient 3 3
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 1 1

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