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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
2015 1 1
2016 3 3
2017 3 3
2018 14 14
2019 22 22
2020 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination /Decontamination Problem 10 10
Unsealed Device Packaging 9 9
Device Contamination with Chemical or Other Material 8 8
Tear, Rip or Hole in Device Packaging 6 6
Material Integrity Problem 6 6
Material Separation 4 4
Break 4 4
Crack 4 4
Material Fragmentation 4 4
Fracture 3 3
Particulates 2 2
Material Protrusion/Extrusion 2 2
Packaging Problem 2 2
Material Deformation 2 2
Device Contaminated During Manufacture or Shipping 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Connection Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Malposition of Device 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Unraveled Material 1 1
Tip 1 1
Knife 1 1
Defective Device 1 1
Detachment of Device or Device Component 1 1
Tube 1 1
Mechanical Problem 1 1
Material Disintegration 1 1
Fluid Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 22 22
No Consequences Or Impact To Patient 18 18
No Patient Involvement 11 11
No Clinical Signs, Symptoms or Conditions 6 6
Foreign Body In Patient 3 3
No Information 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 Customed, Inc II Apr-14-2016
4 Customed, Inc II Sep-03-2015
5 Medline Industries Inc II Oct-07-2020
6 Merit Medical Systems, Inc. II Apr-13-2020
7 Merit Medical Systems, Inc. II Oct-01-2019
8 Navilyst Medical, Inc II Feb-26-2015
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