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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bag, reservoir
Regulation Description Reservoir bag.
Product CodeBTC
Regulation Number 868.5320
Device Class 1

MDR Year MDR Reports MDR Events
2021 5 5
2022 6 6
2023 1 1
2024 5 5
2025 15 15
2026 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 7 7
Gas/Air Leak 5 5
Material Split, Cut or Torn 5 5
Detachment of Device or Device Component 4 4
Leak/Splash 3 3
Fluid/Blood Leak 2 2
Inflation Problem 2 2
Pressure Problem 2 2
Separation Problem 1 1
Device Markings/Labelling Problem 1 1
Disconnection 1 1
Material Disintegration 1 1
Loss of or Failure to Bond 1 1
Burst Container or Vessel 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Material Separation 1 1
Insufficient Flow or Under Infusion 1 1
Device Damaged Prior to Use 1 1
Defective Device 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 31 31
Insufficient Information 4 4
Hypoxia 2 2
Salivary Hypersecretion 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical, Inc. I May-17-2023
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