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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cannula, injection
Product CodeFGY
Regulation Number 878.4200
Device Class 1

MDR Year MDR Reports MDR Events
2017 9 9
2018 7 7
2019 8 8
2020 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 12 12
Break 10 10
Adverse Event Without Identified Device or Use Problem 4 4
Detachment of Device or Device Component 2 2
Leak/Splash 1 1
Entrapment of Device 1 1
Physical Resistance/Sticking 1 1
Patient-Device Incompatibility 1 1
No Apparent Adverse Event 1 1
Detachment Of Device Component 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 7 7
Not Applicable 4 4
No Clinical Signs, Symptoms or Conditions 4 4
No Information 4 4
No Known Impact Or Consequence To Patient 4 4
Pain 4 4
No Code Available 2 2
Necrosis 1 1
Host-Tissue Reaction 1 1
No Consequences Or Impact To Patient 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hobbs Medical, Inc. II Oct-07-2022
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