TPLC - Total Product Life Cycle

show TPLC since

Device	blood/plasma collection device for dna testing
Regulation Description	Blood specimen collection device.
Definition	A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing.
Product Code	PJE
Regulation Number	862.1675
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	245	245
Device Ingredient or Reagent Problem	148	148
Device Contamination with Chemical or Other Material	69	69
Short Fill	26	26
Device Markings/Labelling Problem	20	20
Leak/Splash	7	7
Material Discolored	5	5
Particulates	4	4
Material Deformation	4	4
Fracture	3	3
Improper Chemical Reaction	3	3
Fluid/Blood Leak	3	3
Break	2	2
Volume Accuracy Problem	2	2
Crack	2	2
Component Missing	2	2
Material Twisted/Bent	2	2
Missing Information	2	2
Inaccurate Information	2	2
Improper or Incorrect Procedure or Method	2	2
Separation Problem	1	1
Device Contamination with Body Fluid	1	1
Failure to Obtain Sample	1	1
Contamination	1	1
Product Quality Problem	1	1
Contamination of Device Ingredient or Reagent	1	1
Coagulation in Device or Device Ingredient	1	1
Premature Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	537	537