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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device angiography/angioplasty kit
Regulation Description Angiographic injector and syringe.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOEQ
Regulation Number 870.1650
Device Class 2

MDR Year MDR Reports MDR Events
2017 3 3
2018 14 14
2019 22 22
2020 64 64
2021 54 54

Device Problems MDRs with this Device Problem Events in those MDRs
Unsealed Device Packaging 52 52
Tear, Rip or Hole in Device Packaging 25 25
No Apparent Adverse Event 24 24
Material Frayed 14 14
Material Separation 10 10
Contamination /Decontamination Problem 10 10
Device Contamination with Chemical or Other Material 8 8
Adverse Event Without Identified Device or Use Problem 6 6
Material Integrity Problem 5 5
Material Fragmentation 5 5
Degraded 4 4
Break 3 3
Crack 3 3
Leak/Splash 2 2
Mechanical Problem 2 2
Fluid Leak 2 2
Fracture 2 2
Particulates 2 2
Defective Component 2 2
Material Protrusion/Extrusion 2 2
Packaging Problem 2 2
Material Deformation 2 2
Component Misassembled 1 1
Physical Resistance/Sticking 1 1
Air/Gas in Device 1 1
Detachment of Device or Device Component 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Gas Leak 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Product Quality Problem 1 1
Unraveled Material 1 1
Dull, Blunt 1 1
Defective Device 1 1
Malposition of Device 1 1
Material Discolored 1 1
Material Disintegration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 97 97
No Known Impact Or Consequence To Patient 22 22
No Consequences Or Impact To Patient 14 14
No Patient Involvement 11 11
Foreign Body In Patient 3 3
Air Embolism 3 3
Hemorrhage/Bleeding 2 2
Reaction 2 2
Perforation 1 1
Perforation of Vessels 1 1
No Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 Angiodynamics Inc. (Navilyst Medical Inc.) II Apr-17-2018
3 Cardinal Health 200, LLC II Mar-15-2021
4 Medline Industries Inc II Oct-07-2020
5 Merit Medical Systems, Inc. II Dec-29-2020
6 Merit Medical Systems, Inc. II Apr-13-2020
7 Merit Medical Systems, Inc. II Oct-01-2019
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