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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, blood collection, vacuum-assisted, manual
Regulation Description Vacuum-assisted blood collection system.
Product CodeKST
Regulation Number 864.9125
Device Class 1

MDR Year MDR Reports MDR Events
2016 10 10
2017 1 1
2018 7 7
2019 5 5
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 9 9
Leak/Splash 7 7
Crack 6 6
Appropriate Term/Code Not Available 3 3
Defective Device 2 2
Detachment of Device or Device Component 2 2
Break 2 2
Mechanical Problem 2 2
Material Separation 1 1
Gas Leak 1 1
Material Integrity Problem 1 1
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 13 13
Blood Loss 5 5
No Information 3 3
No Consequences Or Impact To Patient 3 3
Hemorrhage/Bleeding 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hummingbird Med I Jul-05-2016
2 Hummingbird Med I May-20-2016
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