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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device tube, aspirating, flexible, connecting
Product CodeBYY
Regulation Number 880.6740
Device Class 2

MDR Year MDR Reports MDR Events
2017 34 34
2018 12 12
2019 18 18
2020 23 23
2021 11 11
2022 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 67 67
Packaging Problem 15 15
Unsealed Device Packaging 10 10
Device Packaging Compromised 9 9
Device Contamination with Chemical or Other Material 4 4
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Device Damaged Prior to Use 1 1
Physical Resistance/Sticking 1 1
Decrease in Suction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 56 56
No Clinical Signs, Symptoms or Conditions 25 25
Not Applicable 18 18
No Known Impact Or Consequence To Patient 3 3
No Consequences Or Impact To Patient 3 3
Bacterial Infection 1 1
No Information 1 1
Insufficient Information 1 1

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