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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
2019 4 4
2020 2 2
2021 5 5
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 4 4
Leak/Splash 2 2
Material Split, Cut or Torn 2 2
Loss of or Failure to Bond 1 1
Material Puncture/Hole 1 1
Connection Problem 1 1
Product Quality Problem 1 1
Burst Container or Vessel 1 1
Material Disintegration 1 1
Gas/Air Leak 1 1
Electrical Shorting 1 1
No Pressure 1 1
Separation Problem 1 1
Crack 1 1
Defective Device 1 1
Material Rupture 1 1
Insufficient Flow or Under Infusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10 10
No Consequences Or Impact To Patient 2 2
No Known Impact Or Consequence To Patient 1 1
No Patient Involvement 1 1
Bradycardia 1 1
Cardiopulmonary Arrest 1 1
Insufficient Information 1 1
Low Blood Pressure/ Hypotension 1 1
Low Oxygen Saturation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical, Inc. I May-17-2023
2 Teleflex Medical Europe Ltd II Apr-12-2018
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