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	1793	1793
Incorrect, Inadequate or Imprecise Result or Readings	978	978
False Negative Result	225	225
Contamination	198	198
Device Markings/Labelling Problem	121	121
Leak/Splash	86	86
Cross Reactivity	83	83
Contamination of Device Ingredient or Reagent	48	48
Microbial Contamination of Device	26	26
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
Fire	5	5
Data Problem	4	4
Device Ingredient or Reagent Problem	3	3
Communication or Transmission Problem	3	3
Inaccurate Information	3	3
Crack	3	3
Failure to Obtain Sample	3	3
Missing Test Results	3	3
Patient Data Problem	3	3
Product Quality Problem	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	2
Patient-Device Incompatibility	2	2
Device-Device Incompatibility	2	2
Material Integrity Problem	1	1
Alarm Not Visible	1	1
Unable to Obtain Readings	1	1
Failure to Power Up	1	1
Structural Problem	1	1
Expiration Date Error	1	1
Audible Prompt/Feedback Problem	1	1
Misassembly by Users	1	1
Defective Component	1	1
Unintended Electrical Shock	1	1
Device Damaged Prior to Use	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
Mechanical Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Mechanical Jam	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3491	3491
No Consequences Or Impact To Patient	123	123
Insufficient Information	36	36
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	1	1
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