TPLC - Total Product Life Cycle

• Device: container, specimen mailer and storage, sterile
• Regulation Description: Specimen transport and storage container.
• Product Code: KDT
• Regulation Number: 864.3250
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2020	21	21
2021	27	27
2022	39	39
2023	25	25
2024	7	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	18	18
Short Fill	14	14
Missing Information	13	13
Device Markings/Labelling Problem	11	11
Device Contamination with Chemical or Other Material	10	10
Volume Accuracy Problem	9	9
Product Quality Problem	8	8
Fluid/Blood Leak	8	8
Incorrect, Inadequate or Imprecise Result or Readings	7	7
Delivered as Unsterile Product	6	6
Material Protrusion/Extrusion	6	6
Break	4	4
Physical Resistance/Sticking	4	4
Component Missing	3	3
Material Discolored	3	3
Material Deformation	3	3
Difficult to Insert	1	1
Unsealed Device Packaging	1	1
Material Puncture/Hole	1	1
Shielding Failure	1	1
Fitting Problem	1	1
Device Damaged Prior to Use	1	1
Defective Component	1	1
Complete Blockage	1	1
Fracture	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Integrity Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Protective Measures Problem	1	1
Separation Problem	1	1
Inaccurate Information	1	1
Deformation Due to Compressive Stress	1	1
Detachment of Device or Device Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	84	84
Needle Stick/Puncture	11	11
No Known Impact Or Consequence To Patient	10	10
No Consequences Or Impact To Patient	8	8
No Patient Involvement	4	4
Exposure to Body Fluids	1	1
Pain	1	1