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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device support, breathing tube
Regulation Description Breathing tube support.
Product CodeJAY
Regulation Number 868.5280
Device Class 1

MDR Year MDR Reports MDR Events
2021 17 17
2022 11 11
2023 11 11
2024 5 4
2025 8 8
2026 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 21 21
Disconnection 6 6
Break 6 6
Loose or Intermittent Connection 6 6
Stretched 4 4
Premature Separation 3 3
Gas/Air Leak 2 2
Migration 2 2
Device Dislodged or Dislocated 2 2
Loss of or Failure to Bond 2 2
Material Split, Cut or Torn 1 1
Entrapment of Device 1 1
Output Problem 1 1
Device Damaged Prior to Use 1 1
Material Disintegration 1 1
Material Puncture/Hole 1 1
Therapeutic or Diagnostic Output Failure 1 1
Ventilation Problem in Device Environment 1 1
Patient Device Interaction Problem 1 0
Material Fragmentation 1 1
Use of Device Problem 1 1
Component Missing 1 1
Improper Flow or Infusion 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Material Separation 1 1
Tear, Rip or Hole in Device Packaging 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 41 41
Insufficient Information 8 8
Foreign Body In Patient 5 5
Tooth Fracture 2 1
Unspecified Tissue Injury 2 2
High Blood Pressure/ Hypertension 1 1
Necrosis 1 1
Laceration(s) 1 1
Hemorrhage/Bleeding 1 1
Pressure Sores 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CooperSurgical, Inc. II Nov-10-2022
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