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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
2014 1 1
2018 7 7
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 10 10
Device Contamination with Chemical or Other Material 5 5
Material Deformation 4 4
Device Markings/Labelling Problem 3 3
Short Fill 3 3
Volume Accuracy Problem 3 3
Delivered as Unsterile Product 2 2
Contamination 1 1
Difficult to Insert 1 1
Component Missing 1 1
Overfill 1 1
Device Or Device Fragments Location Unknown 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 13 13
No Clinical Signs, Symptoms or Conditions 4 4
No Information 2 2
No Patient Involvement 1 1

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