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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tubing, pressure and accessories
Regulation Description Pressure tubing and accessories.
Product CodeBYX
Regulation Number 868.5860
Device Class 1

MDR Year MDR Reports MDR Events
2020 32 32
2021 13 13
2022 10 10
2023 25 25
2024 25 25
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 20 20
Detachment of Device or Device Component 17 17
Peeled/Delaminated 9 9
Material Twisted/Bent 8 8
Connection Problem 6 6
Gas/Air Leak 6 6
Material Split, Cut or Torn 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Corroded 4 4
Disconnection 4 4
Leak/Splash 3 3
Break 3 3
Difficult or Delayed Positioning 3 3
Device Dislodged or Dislocated 3 3
Positioning Failure 2 2
Loose or Intermittent Connection 2 2
Material Deformation 2 2
Unintended Ejection 2 2
Patient-Device Incompatibility 2 2
Component Missing 2 2
Burst Container or Vessel 2 2
Positioning Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Fluid/Blood Leak 1 1
Fire 1 1
Moisture Damage 1 1
Misconnection 1 1
Obstruction of Flow 1 1
Patient Device Interaction Problem 1 1
Tidal Volume Fluctuations 1 1
Unintended Movement 1 1
No Flow 1 1
Device Damaged by Another Device 1 1
Failure to Deliver 1 1
Pressure Problem 1 1
Improper Flow or Infusion 1 1
Material Fragmentation 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 45 45
No Consequences Or Impact To Patient 27 27
Low Oxygen Saturation 12 12
Insufficient Information 7 7
Skin Tears 4 4
Pain 3 3
Aspiration/Inhalation 3 3
Numbness 3 3
Dyspnea 3 3
No Patient Involvement 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Cough 2 2
Fall 2 2
Headache 2 2
Hematoma 2 2
No Known Impact Or Consequence To Patient 1 1
Bradycardia 1 1
Paralysis 1 1
Bruise/Contusion 1 1
Airway Obstruction 1 1
Skin Inflammation/ Irritation 1 1
Superficial (First Degree) Burn 1 1
Chemical Exposure 1 1
Decreased Respiratory Rate 1 1
Cognitive Changes 1 1
Fatigue 1 1

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