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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fibrin sealant preparation device
Regulation Description Piston syringe.
Product CodeMZM
Regulation Number 880.5860
Device Class 2

MDR Year MDR Reports MDR Events
2021 26 26
2022 103 103
2023 47 47
2024 82 82
2025 81 81
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Disconnect 206 206
Appropriate Term/Code Not Available 77 77
Material Integrity Problem 26 26
Break 19 19
Device Markings/Labelling Problem 14 14
Device Misassembled During Manufacturing /Shipping 12 12
Material Separation 9 9
Connection Problem 8 8
Component Misassembled 6 6
Activation Problem 3 3
Device Contaminated During Manufacture or Shipping 2 2
Device Stenosis 2 2
Difficult to Remove 2 2
Use of Device Problem 2 2
Leak/Splash 1 1
Activation, Positioning or Separation Problem 1 1
Excessive Cooling 1 1
Physical Resistance/Sticking 1 1
Complete Blockage 1 1
Separation Failure 1 1
Defective Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Patient Device Interaction Problem 1 1
Ejection Problem 1 1
Misfire 1 1
Component Missing 1 1
Material Twisted/Bent 1 1
Delivered as Unsterile Product 1 1
Material Deformation 1 1
Coagulation in Device or Device Ingredient 1 1
Failure of Device to Self-Test 1 1
Firing Problem 1 1
No Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 331 331
Insufficient Information 4 4

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