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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tubing, noninvasive
Product CodeGAZ
Regulation Number 880.6740
Device Class 2

MDR Year MDR Reports MDR Events
2014 5 5
2015 1 1
2016 15 15
2017 9 9
2018 10 10
2019 23 23
2020 25 25
2021 18 18
2022 12 12
2023 25 25
2024 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 47 47
Defective Device 12 12
Detachment Of Device Component 12 12
Suction Failure 10 10
Suction Problem 9 9
Disconnection 8 8
Leak/Splash 6 6
Defective Component 6 6
Gas/Air Leak 5 5
Fitting Problem 4 4
Break 4 4
Pressure Problem 3 3
Device Contaminated During Manufacture or Shipping 3 3
Decrease in Suction 3 3
Material Separation 3 3
Device Contamination with Chemical or Other Material 3 3
Fluid/Blood Leak 3 3
Material Twisted/Bent 3 3
Appropriate Term/Code Not Available 3 3
Material Integrity Problem 2 2
Filling Problem 2 2
Noise, Audible 2 2
Key or Button Unresponsive/not Working 2 2
Loose or Intermittent Connection 2 2
Material Rupture 2 2
Device Dislodged or Dislocated 2 2
Inability to Irrigate 1 1
Complete Blockage 1 1
Collapse 1 1
Energy Output Problem 1 1
Crack 1 1
Device Damaged Prior to Use 1 1
Split 1 1
Hole In Material 1 1
No Flow 1 1
Connection Problem 1 1
Nonstandard Device 1 1
Failure to Conduct 1 1
Failure to Advance 1 1
Device Handling Problem 1 1
Unintended Ejection 1 1
Backflow 1 1
Component Missing 1 1
Use of Device Problem 1 1
Difficult to Remove 1 1
Contamination /Decontamination Problem 1 1
Ejection Problem 1 1
Burst Container or Vessel 1 1
Off-Label Use 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 89 89
No Known Impact Or Consequence To Patient 30 30
No Consequences Or Impact To Patient 28 28
No Patient Involvement 9 9
No Information 8 8
Insufficient Information 7 7
Blood Loss 3 3
Patient Problem/Medical Problem 1 1
Death 1 1
Pulmonary Emphysema 1 1
Bone Fracture(s) 1 1
Injury 1 1
Foreign Body In Patient 1 1
Swelling 1 1
Fall 1 1
Vitreous Hemorrhage 1 1
Hemorrhage/Bleeding 1 1
Decreased Respiratory Rate 1 1
Pulmonary Embolism 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health II Sep-22-2010
2 ConMed Corporation II Oct-18-2016
3 Medtronic Minimally Invasive Therapies Group II Mar-05-2018
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