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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
2021 13 14
2022 10 10
2023 25 25
2024 25 25
2025 67 68
2026 39 40

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 44 44
Connection Problem 24 24
Loose or Intermittent Connection 21 21
Detachment of Device or Device Component 19 19
Gas/Air Leak 8 8
Peeled/Delaminated 8 8
Disconnection 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Material Split, Cut or Torn 6 6
Material Deformation 5 5
Obstruction of Flow 5 5
Crack 5 5
Corroded 4 4
Insufficient Flow or Under Infusion 4 4
Fitting Problem 4 4
Leak/Splash 3 3
Difficult or Delayed Positioning 3 3
Break 3 3
Infusion or Flow Problem 3 3
Incomplete or Inadequate Connection 3 3
Burst Container or Vessel 2 2
Positioning Failure 2 2
Unintended Ejection 2 2
Fire 2 2
Component Missing 2 2
Patient-Device Incompatibility 2 2
Material Integrity Problem 2 2
Improper Flow or Infusion 1 1
Positioning Problem 1 1
Pressure Problem 1 1
Unintended Movement 1 2
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1
Device Damaged by Another Device 1 1
Failure to Deliver 1 1
Fluid/Blood Leak 1 1
Material Fragmentation 1 1
Material Too Rigid or Stiff 1 1
Tidal Volume Fluctuations 1 1
Mechanical Problem 1 1
Misconnection 1 1
Moisture Damage 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 93 96
Low Oxygen Saturation 44 44
Insufficient Information 22 22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Skin Tears 4 4
Aspiration/Inhalation 3 3
Numbness 3 3
Dyspnea 3 3
Fall 3 3
Pain 3 3
Hematoma 2 2
Cough 2 2
Headache 2 2
Superficial (First Degree) Burn 1 1
Hip Fracture 1 1
Fatigue 1 1
Skin Inflammation/ Irritation 1 1
Cognitive Changes 1 1
Chemical Exposure 1 1
Paralysis 1 1
Partial thickness (Second Degree) Burn 1 1
Airway Obstruction 1 1
Ventilator Dependent 1 1
Decreased Respiratory Rate 1 1
Full thickness (Third Degree) Burn 1 1
Bruise/Contusion 1 1

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