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TPLC
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show TPLC since
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Device
container, empty, for collection & processing of blood & blood components
Product Code
KSR
Regulation Number
864.9100
Device Class
2
Premarket Reviews
Manufacturer
Decision
FENWAL INC
SUBSTANTIALLY EQUIVALENT
1
FRESENIUS KABI AG
SUBSTANTIALLY EQUIVALENT
4
HAEMONETICS MANUFACTURING INC.
SUBSTANTIALLY EQUIVALENT
2
ORIGEN BIOMEDICAL
SUBSTANTIALLY EQUIVALENT
2
PURIBLOOD MEDICAL CO. LTD.
SUBSTANTIALLY EQUIVALENT
1
TERUMO BCT, INC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
11
11
2015
8
8
2016
5
5
2017
4
4
2018
3
3
2019
9
9
2020
21
21
2021
17
17
2022
11
11
2023
20
20
2024
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fracture
33
33
Crack
17
17
Appropriate Term/Code Not Available
17
17
Insufficient Information
8
8
Leak/Splash
8
8
Fluid/Blood Leak
8
8
Detachment of Device or Device Component
7
7
Adverse Event Without Identified Device or Use Problem
7
7
Break
6
6
Burst Container or Vessel
6
6
Material Puncture/Hole
5
5
Material Integrity Problem
4
4
Loose or Intermittent Connection
3
3
Particulates
2
2
Device Disinfection Or Sterilization Issue
2
2
Device Operates Differently Than Expected
2
2
Improper or Incorrect Procedure or Method
2
2
Defective Component
2
2
Component Missing
2
2
Tear, Rip or Hole in Device Packaging
1
1
Contamination of Device Ingredient or Reagent
1
1
Product Quality Problem
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Material Rupture
1
1
Use of Device Problem
1
1
Restricted Flow rate
1
1
Failure To Adhere Or Bond
1
1
Material Frayed
1
1
Hole In Material
1
1
Filtration Problem
1
1
Free or Unrestricted Flow
1
1
Human-Device Interface Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Deformation
1
1
Device Markings/Labelling Problem
1
1
Protective Measures Problem
1
1
Scratched Material
1
1
Therapeutic or Diagnostic Output Failure
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
42
42
No Known Impact Or Consequence To Patient
40
40
Insufficient Information
10
10
No Information
8
8
No Patient Involvement
5
5
Unspecified Infection
2
2
Needle Stick/Puncture
2
2
Pain
1
1
Toxicity
1
1
Osteopenia/ Osteoporosis
1
1
Hemorrhage/Bleeding
1
1
Thromboembolism
1
1
Renal Failure
1
1
Low Blood Pressure/ Hypotension
1
1
Respiratory Failure
1
1
Infection, Indirect
1
1
Disseminated Intravascular Coagulation (DIC)
1
1
Tachycardia
1
1
Muscle/Tendon Damage
1
1
No Consequences Or Impact To Patient
1
1
Bone Fracture(s)
1
1
Death
1
1
Abdominal Pain
1
1
No Code Available
1
1
Chemical Exposure
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
DeRoyal Industries Inc
II
Apr-12-2012
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