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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device adaptor, holder, syringe
Product CodeIQG
Regulation Number 890.5050
Device Class 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 2 2
2020 4 4
2022 4 4
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2 2
Material Fragmentation 1 1
Mechanical Problem 1 1
Material Separation 1 1
Defective Component 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Fail-Safe Problem 1 1
Improper Flow or Infusion 1 1
Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
No Known Impact Or Consequence To Patient 3 3
No Information 1 1
Insufficient Information 1 1
No Consequences Or Impact To Patient 1 1

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