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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 163 163

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 285 285
Use of Device Problem 238 238
Material Split, Cut or Torn 55 55
Leak/Splash 41 41
Inflation Problem 36 36
Break 26 26
Defective Component 26 26
Material Separation 16 16
Material Rupture 14 14
Fluid/Blood Leak 13 13
Appropriate Term/Code Not Available 11 11
Insufficient Information 10 10
Detachment of Device or Device Component 8 8
Obstruction of Flow 8 8
Material Integrity Problem 7 7
Crack 6 6
Mechanical Problem 5 5
Human-Device Interface Problem 5 5
Device Damaged Prior to Use 4 4
Installation-Related Problem 4 4
Nonstandard Device 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Material Fragmentation 3 3
Component Missing 3 3
Sharp Edges 3 3
Material Deformation 3 3
Partial Blockage 3 3
Fitting Problem 3 3
Material Puncture/Hole 2 2
Material Discolored 2 2
Physical Resistance/Sticking 2 2
Patient-Device Incompatibility 1 1
Complete Blockage 1 1
Device Markings/Labelling Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Positioning Failure 1 1
Peeled/Delaminated 1 1
Insufficient Flow or Under Infusion 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Burst Container or Vessel 1 1
Tear, Rip or Hole in Device Packaging 1 1
Ambient Noise Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Device-Device Incompatibility 1 1
No Apparent Adverse Event 1 1
Fracture 1 1
Connection Problem 1 1
Material Too Soft/Flexible 1 1
Failure to Deflate 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 519 519
No Patient Involvement 109 109
Unintended Extubation 54 54
No Consequences Or Impact To Patient 48 48
Extubate 24 24
Insufficient Information 20 20
Low Oxygen Saturation 17 17
No Known Impact Or Consequence To Patient 8 8
Unspecified Tissue Injury 7 7
Injury 6 6
Hemorrhage/Bleeding 4 4
Tissue Breakdown 4 4
No Information 3 3
Pain 3 3
Hypoventilation 2 2
Pneumothorax 2 2
Blood Loss 2 2
Arrhythmia 1 1
Adult Respiratory Distress Syndrome 1 1
Perforation of Esophagus 1 1
Foreign Body In Patient 1 1
Dyspnea 1 1
Laceration(s) 1 1
Dysphagia/ Odynophagia 1 1
Therapeutic Response, Decreased 1 1
Sore Throat 1 1
Low Blood Pressure/ Hypotension 1 1
Ventilator Dependent 1 1
Decreased Respiratory Rate 1 1
Fistula 1 1
Unintended Radiation Exposure 1 1

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