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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device culture media, anaerobic transport
Product CodeJSL
Regulation Number 866.2390
Device Class 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 5 5
2021 2 2
2022 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 6 6
Material Deformation 4 4
Short Fill 3 3
Volume Accuracy Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Device Markings/Labelling Problem 2 2
Contamination 1 1
Difficult to Insert 1 1
Overfill 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 6 6
No Clinical Signs, Symptoms or Conditions 4 4
No Patient Involvement 1 1
No Information 1 1

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