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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
2018 15 15
2019 18 18
2020 5 5
2021 11 11
2022 5 5
2023 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Break 21 21
Detachment of Device or Device Component 8 8
Defective Device 7 7
Fracture 7 7
Material Fragmentation 6 6
Kinked 3 3
Defective Component 3 3
Physical Resistance/Sticking 3 3
Device Markings/Labelling Problem 2 2
Material Too Soft/Flexible 2 2
Failure to Disconnect 2 2
Material Too Rigid or Stiff 2 2
Material Separation 2 2
Inadequacy of Device Shape and/or Size 2 2
Use of Device Problem 1 1
Device Damaged Prior to Use 1 1
False Alarm 1 1
Obstruction of Flow 1 1
Expiration Date Error 1 1
Crack 1 1
Entrapment of Device 1 1
Flaked 1 1
Material Integrity Problem 1 1
Output Problem 1 1
Unintended Movement 1 1
Device Fell 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 16 16
No Known Impact Or Consequence To Patient 11 11
No Clinical Signs, Symptoms or Conditions 11 11
Insufficient Information 9 9
Extubate 5 5
Foreign Body In Patient 5 5
Laceration(s) 3 3
Unintended Extubation 3 3
Aspiration/Inhalation 2 2
Death 2 2
No Information 1 1
No Code Available 1 1

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