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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, anastomotic, microvascular
Regulation Description Implantable clip.
Product CodeMVR
Regulation Number 878.4300
Device Class 2

MDR Year MDR Reports MDR Events
2020 43 43
2021 35 35
2022 18 18
2023 28 28
2024 38 38
2025 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 34 34
Disconnection 29 29
Difficult to Open or Close 25 25
Detachment of Device or Device Component 23 23
Adverse Event Without Identified Device or Use Problem 19 19
Device Dislodged or Dislocated 14 14
Incomplete or Inadequate Connection 10 10
Loose or Intermittent Connection 8 8
Break 7 7
Fitting Problem 3 3
Material Deformation 3 3
Defective Component 2 2
Misconnection 2 2
Failure to Disconnect 2 2
Failure to Sense 1 1
Component Missing 1 1
Obstruction of Flow 1 1
Device Alarm System 1 1
Crack 1 1
Entrapment of Device 1 1
Fluid/Blood Leak 1 1
Fracture 1 1
Unintended Movement 1 1
Physical Resistance/Sticking 1 1
Product Quality Problem 1 1
Failure to Align 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 120 120
No Consequences Or Impact To Patient 27 27
Injury 12 12
No Patient Involvement 8 8
Perforation of Vessels 6 6
Insufficient Information 3 3
Thrombus 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Discomfort 1 1
Foreign Body Sensation in Eye 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jan-30-2021
2 Baxter Healthcare Corporation II Jun-30-2020
3 Baxter Healthcare Corporation II Apr-08-2020
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