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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cannula, injection
Regulation Description Introduction/drainage catheter and accessories.
Product CodeFGY
Regulation Number 878.4200
Device Class 1

MDR Year MDR Reports MDR Events
2016 5 5
2017 9 9
2018 7 7
2019 8 8
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 13 13
Fracture 12 12
Cannula 7 7
Adverse Event Without Identified Device or Use Problem 4 4
Tip 3 3
No Apparent Adverse Event 1 1
Patient-Device Incompatibility 1 1
Detachment of Device or Device Component 1 1
Fluid Leak 1 1
Detachment Of Device Component 1 1
Entrapment of Device 1 1
Leak/Splash 1 1
Unintended Collision 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 8 8
No Information 6 6
Not Applicable 4 4
Pain 4 4
No Known Impact Or Consequence To Patient 4 4
Device Embedded In Tissue or Plaque 3 3
No Code Available 2 2
Necrosis 1 1
Host-Tissue Reaction 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biologic Therapies, Inc II Apr-02-2015
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