Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device container, empty, for collection & processing of blood & blood components
Product CodeKSR
Regulation Number 864.9100
Device Class 2


Premarket Reviews
ManufacturerDecision
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 2
TERUMO BCT, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 21 21
2021 17 17
2022 11 11
2023 20 20
2024 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 27 27
Appropriate Term/Code Not Available 21 21
Insufficient Information 19 19
Crack 13 13
Adverse Event Without Identified Device or Use Problem 7 7
Detachment of Device or Device Component 7 7
Burst Container or Vessel 6 6
Fluid/Blood Leak 5 5
Break 4 4
Material Puncture/Hole 4 4
Loose or Intermittent Connection 3 3
Leak/Splash 2 2
Material Integrity Problem 2 2
Material Frayed 1 1
Defective Component 1 1
Particulates 1 1
Product Quality Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Contamination with Chemical or Other Material 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 59 59
No Known Impact Or Consequence To Patient 21 21
Insufficient Information 11 11
Chemical Exposure 1 1
Pain 1 1
Muscle/Tendon Damage 1 1

-
-