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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
Detachment Of Device Component 12 12
Defective Device 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
Break 4 4
Fitting Problem 4 4
Fluid/Blood Leak 3 3
Pressure Problem 3 3
Appropriate Term/Code Not Available 3 3
Device Contaminated During Manufacture or Shipping 3 3
Device Contamination with Chemical or Other Material 3 3
Material Separation 3 3
Material Twisted/Bent 3 3
Decrease in Suction 3 3
Noise, Audible 2 2
Loose or Intermittent Connection 2 2
Filling Problem 2 2
Device Dislodged or Dislocated 2 2
Material Integrity Problem 2 2
Key or Button Unresponsive/not Working 2 2
Material Rupture 2 2
Hole In Material 1 1
No Flow 1 1
Connection Problem 1 1
Nonstandard Device 1 1
Failure to Advance 1 1
Failure to Conduct 1 1
Product Quality Problem 1 1
Failure to Prime 1 1
Device Handling Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Failure to Cut 1 1
Insufficient Flow or Under Infusion 1 1
Component Missing 1 1
Use of Device Problem 1 1
Unintended Ejection 1 1
Backflow 1 1
Human Factors Issue 1 1
Ejection Problem 1 1
Contamination /Decontamination Problem 1 1
Difficult to Remove 1 1
Energy Output Problem 1 1
Inability to Irrigate 1 1
Collapse 1 1
Complete Blockage 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
Bone Fracture(s) 1 1
Pulmonary Emphysema 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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