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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device evacuator, gastro-urology
Product CodeKQT
Regulation Number 876.4370
Device Class 2

MDR Year MDR Reports MDR Events
2019 4 4
2020 16 16
2021 11 11
2022 8 8
2023 4 4
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Disconnection 7 7
Fluid/Blood Leak 6 6
Device Contaminated During Manufacture or Shipping 5 5
Material Fragmentation 4 4
Fitting Problem 4 4
Detachment of Device or Device Component 3 3
Device Contamination with Chemical or Other Material 3 3
Filling Problem 3 3
Break 3 3
Appropriate Term/Code Not Available 3 3
Component Misassembled 2 2
Material Split, Cut or Torn 2 2
Decrease in Suction 2 2
Material Discolored 2 2
Loose or Intermittent Connection 2 2
Off-Label Use 1 1
Difficult to Remove 1 1
Inadequacy of Device Shape and/or Size 1 1
Contamination /Decontamination Problem 1 1
Contamination 1 1
Fracture 1 1
Suction Failure 1 1
Missing Information 1 1
Patient Device Interaction Problem 1 1
Naturally Worn 1 1
Packaging Problem 1 1
Inability to Auto-Fill 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 26 26
No Consequences Or Impact To Patient 13 13
No Known Impact Or Consequence To Patient 10 10
No Patient Involvement 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Unspecified Tissue Injury 1 1
Tissue Breakdown 1 1
Needle Stick/Puncture 1 1

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