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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tube, bronchial (w/wo connector)
Product CodeBTS
Regulation Number 868.5720
Device Class 2

MDR Year MDR Reports MDR Events
2019 122 122
2020 91 91
2021 110 110
2022 140 140
2023 162 162
2024 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 258 258
Use of Device Problem 193 193
Material Split, Cut or Torn 46 46
Inflation Problem 32 32
Defective Component 24 24
Break 23 23
Leak/Splash 17 17
Material Separation 15 15
Material Rupture 14 14
Fluid/Blood Leak 13 13
Insufficient Information 10 10
Appropriate Term/Code Not Available 10 10
Obstruction of Flow 8 8
Detachment of Device or Device Component 7 7
Material Integrity Problem 7 7
Crack 6 6
Mechanical Problem 5 5
Human-Device Interface Problem 4 4
Installation-Related Problem 4 4
Device Damaged Prior to Use 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Material Deformation 3 3
Component Missing 3 3
Partial Blockage 3 3
Material Fragmentation 3 3
Sharp Edges 3 3
Physical Resistance/Sticking 2 2
Material Puncture/Hole 2 2
Nonstandard Device 2 2
Material Discolored 2 2
Disconnection 1 1
Fracture 1 1
Positioning Failure 1 1
Burst Container or Vessel 1 1
Complete Blockage 1 1
Peeled/Delaminated 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Markings/Labelling Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Fitting Problem 1 1
Patient-Device Incompatibility 1 1
Ambient Noise Problem 1 1
Connection Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
No Apparent Adverse Event 1 1
Material Too Soft/Flexible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 415 415
No Patient Involvement 109 109
No Consequences Or Impact To Patient 48 48
Unintended Extubation 45 45
Extubate 24 24
Insufficient Information 17 17
Low Oxygen Saturation 15 15
No Known Impact Or Consequence To Patient 8 8
Injury 6 6
Unspecified Tissue Injury 5 5
Tissue Breakdown 4 4
No Information 3 3
Pain 3 3
Hemorrhage/Bleeding 3 3
Hypoventilation 2 2
Pneumothorax 2 2
Blood Loss 2 2
Foreign Body In Patient 1 1
Decreased Respiratory Rate 1 1
Unintended Radiation Exposure 1 1
Therapeutic Response, Decreased 1 1
Ventilator Dependent 1 1
Sore Throat 1 1
Perforation of Esophagus 1 1
Laceration(s) 1 1
Low Blood Pressure/ Hypotension 1 1
Adult Respiratory Distress Syndrome 1 1
Dysphagia/ Odynophagia 1 1
Dyspnea 1 1
Fistula 1 1

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