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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
Product CodeBYX
Regulation Number 868.5860
Device Class 1

MDR Year MDR Reports MDR Events
2019 16 16
2020 32 32
2021 13 13
2022 10 10
2023 25 25
2024 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 18 18
Detachment of Device or Device Component 18 18
Peeled/Delaminated 9 9
Adverse Event Without Identified Device or Use Problem 7 7
Break 6 6
Connection Problem 6 6
Material Twisted/Bent 6 6
Disconnection 5 5
Material Split, Cut or Torn 5 5
Corroded 4 4
Material Deformation 4 4
Gas/Air Leak 4 4
Device Dislodged or Dislocated 3 3
No Flow 2 2
Loose or Intermittent Connection 2 2
Difficult or Delayed Positioning 2 2
Component Missing 2 2
Unintended Ejection 2 2
Positioning Failure 2 2
Insufficient Information 2 2
Patient-Device Incompatibility 2 2
Complete Blockage 2 2
Burst Container or Vessel 2 2
Failure to Deliver 1 1
Patient Device Interaction Problem 1 1
Material Fragmentation 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Moisture Damage 1 1
Positioning Problem 1 1
Tidal Volume Fluctuations 1 1
Obstruction of Flow 1 1
Device Fell 1 1
Improper Flow or Infusion 1 1
Tube(s), defective 1 1
Device Damaged by Another Device 1 1
Unintended Movement 1 1
Misconnection 1 1
Material Puncture/Hole 1 1
Collapse 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1
Suction Problem 1 1
Fire 1 1
Adaptor, failure of 1 1
Device Issue 1 1
Pressure Problem 1 1
Fluid/Blood Leak 1 1
Unintended Collision 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 38 38
No Consequences Or Impact To Patient 30 30
Low Oxygen Saturation 11 11
No Known Impact Or Consequence To Patient 6 6
Skin Tears 5 5
No Patient Involvement 4 4
Insufficient Information 4 4
Dyspnea 4 4
Aspiration/Inhalation 3 3
Numbness 3 3
Fall 3 3
Pain 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hematoma 2 2
Cough 2 2
Headache 2 2
Airway Obstruction 2 2
Superficial (First Degree) Burn 1 1
Patient Problem/Medical Problem 1 1
Fatigue 1 1
No Information 1 1
Skin Inflammation/ Irritation 1 1
Bone Fracture(s) 1 1
Chest Tightness/Pressure 1 1
Cognitive Changes 1 1
Chemical Exposure 1 1
Paralysis 1 1
Asphyxia 1 1
Bradycardia 1 1
Decreased Respiratory Rate 1 1
Bruise/Contusion 1 1

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