TPLC - Total Product Life Cycle

show TPLC since

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	34	34
Appropriate Term/Code Not Available	18	18
Crack	17	17
Adverse Event Without Identified Device or Use Problem	9	9
Insufficient Information	8	8
Leak/Splash	8	8
Fluid/Blood Leak	8	8
Detachment of Device or Device Component	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	43	43
No Known Impact Or Consequence To Patient	40	40
Insufficient Information	10	10
No Information	8	8
No Patient Involvement	5	5
Needle Stick/Puncture	2	2
Unspecified Infection	2	2
Pain	1	1
Renal Failure	1	1
Tachycardia	1	1
No Consequences Or Impact To Patient	1	1
Infection, Indirect	1	1
Toxicity	1	1
Abdominal Pain	1	1
Death	1	1
Disseminated Intravascular Coagulation (DIC)	1	1
Bone Fracture(s)	1	1
Hemorrhage/Bleeding	1	1
Low Blood Pressure/ Hypotension	1	1
Respiratory Failure	1	1
Chemical Exposure	1	1
Osteopenia/ Osteoporosis	1	1
Thromboembolism	1	1
No Code Available	1	1
Muscle/Tendon Damage	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	DeRoyal Industries Inc	II	Apr-12-2012