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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
Regulation Description Vacuum-powered body fluid suction apparatus.
Product CodeBYY
Regulation Number 880.6740
Device Class 2

MDR Year MDR Reports MDR Events
2020 23 23
2021 11 11
2022 11 11
2023 11 11
2024 3 3
2025 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 51 51
Failure to Seal 8 8
Fitting Problem 2 2
Detachment of Device or Device Component 2 2
Break 1 1
Physical Resistance/Sticking 1 1
Suction Failure 1 1
Contamination 1 1
Component Missing 1 1
Unexpected Color 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 51 51
No Patient Involvement 15 15
Insufficient Information 2 2
No Consequences Or Impact To Patient 2 2
Unspecified Immune System Problem 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DeRoyal Industries Inc II Feb-14-2025
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