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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device set, transfer (blood/plasma)
Product CodeKSB
Regulation Number 864.9875
Device Class 2


Premarket Reviews
ManufacturerDecision
GENESISBPS, LLC
  SUBSTANTIALLY EQUIVALENT 1
WUHAN BMS MEDICALTECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Break 9 9
Use of Device Problem 9 9
Leak/Splash 7 7
Ejection Problem 4 4
Activation, Positioning or Separation Problem 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Appropriate Term/Code Not Available 1 1
Structural Problem 1 1
Product Quality Problem 1 1
Unintended Ejection 1 1
Failure to Eject 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 10 10
No Consequences Or Impact To Patient 1 1

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