TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	2224	2224
False Positive Result	2173	2173
False Negative Result	385	385
Contamination	335	335
Device Markings/Labelling Problem	124	124
Cross Reactivity	101	101
Leak/Splash	101	101
Contamination of Device Ingredient or Reagent	47	47
Microbial Contamination of Device	31	31
Unintended Movement	19	19
Missing Information	19	19
Fluid/Blood Leak	17	17
Break	14	14
Device Contamination with Chemical or Other Material	13	13
Inaccurate Information	8	8
Fire	6	6
Contamination /Decontamination Problem	5	5
Device Ingredient or Reagent Problem	4	4
Crack	4	4
Data Problem	4	4
Patient Data Problem	3	3
Incorrect Measurement	3	3
Mechanical Problem	3	3
Failure to Obtain Sample	3	3
Patient-Device Incompatibility	2	2
Communication or Transmission Problem	2	2
Device-Device Incompatibility	2	2
Device Damaged Prior to Use	2	2
Labelling, Instructions for Use or Training Problem	2	2
Product Quality Problem	2	2
Missing Test Results	2	2
Manufacturing, Packaging or Shipping Problem	2	3
Material Integrity Problem	1	1
Mechanical Jam	1	1
Improper Flow or Infusion	1	1
Noise, Audible	1	1
Unintended Electrical Shock	1	1
Audible Prompt/Feedback Problem	1	1
Excessive Heating	1	1
Melted	1	1
Misassembled	1	1
Failure to Power Up	1	1
Alarm Not Visible	1	1
Backflow	1	1
Defective Component	1	1
Improper or Incorrect Procedure or Method	1	1
Device Contamination with Body Fluid	1	1
Structural Problem	1	1
Expiration Date Error	1	2
Application Network Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5489	5490
No Consequences Or Impact To Patient	116	116
Insufficient Information	37	37
Bacterial Infection	10	10
Sepsis	5	5
No Information	5	5
No Patient Involvement	5	5
Misdiagnosis	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Air Embolism	1	1
Drug Resistant Bacterial Infection	1	1
Fungal Infection	1	1
Crushing Injury	1	1
Local Reaction	1	1
Blister	1	1
Fever	1	1
Pleural Effusion	1	1