Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device tubing, pressure and accessories
Regulation Description Pressure tubing and accessories.
Product CodeBYX
Regulation Number 868.5860
Device Class 1

MDR Year MDR Reports MDR Events
2021 13 14
2022 10 10
2023 25 25
2024 25 25
2025 67 68
2026 48 49

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 50 50
Connection Problem 24 24
Loose or Intermittent Connection 23 23
Detachment of Device or Device Component 19 19
Gas/Air Leak 9 9
Peeled/Delaminated 8 8
Disconnection 7 7
Material Split, Cut or Torn 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Obstruction of Flow 6 6
Crack 5 5
Material Deformation 5 5
Fitting Problem 4 4
Corroded 4 4
Incomplete or Inadequate Connection 4 4
Insufficient Flow or Under Infusion 4 4
Leak/Splash 3 3
Break 3 3
Difficult or Delayed Positioning 3 3
Infusion or Flow Problem 3 3
Component Missing 2 2
Unintended Ejection 2 2
Positioning Failure 2 2
Material Integrity Problem 2 2
Patient-Device Incompatibility 2 2
Fire 2 2
Burst Container or Vessel 2 2
Material Too Rigid or Stiff 1 1
Material Fragmentation 1 1
Failure to Deliver 1 1
Moisture Damage 1 1
Improper Flow or Infusion 1 1
Positioning Problem 1 1
Device Damaged by Another Device 1 1
Tidal Volume Fluctuations 1 1
Device Fell 1 1
Unintended Movement 1 2
Misconnection 1 1
Mechanical Problem 1 1
Appropriate Term/Code Not Available 1 1
Pressure Problem 1 1
Fluid/Blood Leak 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 96 99
Low Oxygen Saturation 49 49
Insufficient Information 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Skin Tears 4 4
Aspiration/Inhalation 3 3
Numbness 3 3
Dyspnea 3 3
Fall 3 3
Pain 3 3
Hematoma 2 2
Cough 2 2
Headache 2 2
Superficial (First Degree) Burn 1 1
Hip Fracture 1 1
Fatigue 1 1
Skin Inflammation/ Irritation 1 1
Cognitive Changes 1 1
Chemical Exposure 1 1
Paralysis 1 1
Partial thickness (Second Degree) Burn 1 1
Airway Obstruction 1 1
Ventilator Dependent 1 1
Decreased Respiratory Rate 1 1
Full thickness (Third Degree) Burn 1 1
Bruise/Contusion 1 1

-
-