TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
MEDRAD, INC. / BAYER MEDICAL CARE, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	24	24
Fluid/Blood Leak	18	18
Break	12	12
Defective Component	12	12
No Flow	11	11
Detachment Of Device Component	10	10
Disconnection	10	10
Suction Failure	8	8
Device Operates Differently Than Expected	7	7
Crack	6	6
Occlusion Within Device	6	6
Material Separation	5	5
Hole In Material	5	5
Insufficient Flow or Under Infusion	5	5
Detachment of Device or Device Component	5	5
Device Contamination with Chemical or Other Material	4	4
Loose or Intermittent Connection	4	4
Improper or Incorrect Procedure or Method	3	3
Failure to Deliver	3	3
Tear, Rip or Hole in Device Packaging	3	3
Split	3	3
Defective Device	3	3
Device Packaging Compromised	3	3
No Apparent Adverse Event	3	3
Insufficient Information	3	3
Adverse Event Without Identified Device or Use Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Material Integrity Problem	2	2
Material Disintegration	2	2
Complete Blockage	2	2
Accessory Incompatible	1	1
Air Leak	1	1
Disassembly	1	1
Component Falling	1	1
Filling Problem	1	1
Restricted Flow rate	1	1
Delivered as Unsterile Product	1	1
Difficult to Flush	1	1
Device Displays Incorrect Message	1	1
Connection Problem	1	1
Physical Resistance	1	1
Inaccurate Delivery	1	1
Residue After Decontamination	1	1
Suction Problem	1	1
Device Slipped	1	1
Sticking	1	1
Particulates	1	1
Material Twisted/Bent	1	1
Free or Unrestricted Flow	1	1
Improper Flow or Infusion	1	1
Infusion or Flow Problem	1	1
Positioning Problem	1	1
Unintended Movement	1	1
Material Split, Cut or Torn	1	1
Physical Resistance/Sticking	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	43	43
No Known Impact Or Consequence To Patient	34	34
No Clinical Signs, Symptoms or Conditions	28	28
Insufficient Information	7	7
Blood Loss	5	5
No Patient Involvement	4	4
No Information	4	4
Hemorrhage/Bleeding	3	3
Missed Dose	2	2
Chemical Exposure	2	2
Exposure to Body Fluids	2	2
No Code Available	1	1
Intermenstrual Bleeding	1	1
Therapeutic Response, Decreased	1	1
Complaint, Ill-Defined	1	1
Low Blood Pressure/ Hypotension	1	1
Overdose	1	1
Pain	1	1