TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	2163	2163
Incorrect, Inadequate or Imprecise Result or Readings	2130	2130
Contamination	333	333
False Negative Result	279	279
Device Markings/Labelling Problem	126	126
Cross Reactivity	101	101
Leak/Splash	95	95
Contamination of Device Ingredient or Reagent	48	48
Microbial Contamination of Device	31	31
Unintended Movement	20	20
Missing Information	19	19
Fluid/Blood Leak	17	17
Break	15	15
Device Contamination with Chemical or Other Material	13	13
Contamination /Decontamination Problem	12	12
Inaccurate Information	8	8
Fire	6	6
Crack	4	4
Data Problem	4	4
Device Ingredient or Reagent Problem	3	3
Communication or Transmission Problem	3	3
Failure to Obtain Sample	3	3
Patient Data Problem	3	3
Missing Test Results	3	3
Product Quality Problem	2	2
Incorrect Measurement	2	2
Labelling, Instructions for Use or Training Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	3
Patient-Device Incompatibility	2	2
Device Damaged Prior to Use	2	2
Mechanical Problem	2	2
Device-Device Incompatibility	2	2
Alarm Not Visible	1	1
Unable to Obtain Readings	1	1
Failure to Power Up	1	1
Improper Flow or Infusion	1	1
Material Integrity Problem	1	1
Defective Component	1	1
Structural Problem	1	1
Audible Prompt/Feedback Problem	1	1
Misassembled	1	1
Misassembly by Users	1	1
Expiration Date Error	1	2
Unintended Electrical Shock	1	1
Physical Resistance/Sticking	1	1
Output Problem	1	1
Excessive Heating	1	1
Device Contamination with Body Fluid	1	1
Difficult to Open or Close	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5249	5250
No Consequences Or Impact To Patient	123	123
Insufficient Information	37	37
No Known Impact Or Consequence To Patient	19	19
No Patient Involvement	10	10
Bacterial Infection	10	10
Misdiagnosis	6	6
Sepsis	5	5
No Information	5	5
Death	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Drug Resistant Bacterial Infection	1	1
Fungus	1	1
Fungal Infection	1	1
Crushing Injury	1	1
Local Reaction	1	1
Blister	1	1
Fever	1	1
Pleural Effusion	1	1
Pain	1	1
Headache	1	1