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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bag, reservoir
Product CodeBTC
Regulation Number 868.5320
Device Class 1


Premarket Reviews
ManufacturerDecision
PEDIA, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 12 12
2019 4 4
2020 2 2
2021 5 5
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 9 9
Detachment of Device or Device Component 4 4
Disconnection 3 3
Material Rupture 1 1
Connection Problem 1 1
Material Split, Cut or Torn 1 1
Separation Problem 1 1
Crack 1 1
Fluid Leak 1 1
Material Puncture/Hole 1 1
Defective Device 1 1
Electrical Shorting 1 1
No Pressure 1 1
Burst Container or Vessel 1 1
Material Disintegration 1 1
Gas Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 11 11
No Clinical Signs, Symptoms or Conditions 8 8
No Known Impact Or Consequence To Patient 4 4
Insufficient Information 1 1
Cardiopulmonary Arrest 1 1
No Patient Involvement 1 1
Low Oxygen Saturation 1 1
Bradycardia 1 1
Chemical Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Teleflex Medical Europe Ltd II Apr-12-2018
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