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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stylet, tracheal tube
Product CodeBSR
Regulation Number 868.5790
Device Class 1

MDR Year MDR Reports MDR Events
2019 18 18
2020 5 5
2021 11 11
2022 5 5
2023 19 19
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Break 20 20
Defective Device 11 11
Detachment of Device or Device Component 9 9
Fracture 6 6
Material Separation 4 4
Defective Component 3 3
Material Fragmentation 3 3
Failure to Disconnect 3 3
Material Integrity Problem 2 2
Appropriate Term/Code Not Available 2 2
Material Too Soft/Flexible 2 2
Physical Resistance/Sticking 2 2
Material Too Rigid or Stiff 2 2
False Alarm 1 1
Difficult to Remove 1 1
Crack 1 1
Entrapment of Device 1 1
Flaked 1 1
Obstruction of Flow 1 1
Contamination /Decontamination Problem 1 1
Unstable 1 1
Use of Device Problem 1 1
Device Damaged Prior to Use 1 1
Device Fell 1 1
Unintended Movement 1 1
Device Markings/Labelling Problem 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20 20
Insufficient Information 12 12
Foreign Body In Patient 9 9
No Consequences Or Impact To Patient 8 8
No Known Impact Or Consequence To Patient 6 6
Unintended Extubation 4 4
Laceration(s) 3 3
Respiratory Distress Syndrome of Newborns 2 2
Swelling/ Edema 2 2
Airway Obstruction 2 2
Apnea 2 2
Aspiration/Inhalation 2 2
Bronchospasm 2 2
Death 1 1
Hypoxia 1 1
Extubate 1 1
Obstruction/Occlusion 1 1
Low Oxygen Saturation 1 1
No Information 1 1
No Code Available 1 1

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