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
2021	27	27
2022	39	39
2023	25	25
2024	7	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Missing Information	13	13
Leak/Splash	11	11
Device Markings/Labelling Problem	11	11
Short Fill	8	8
Fluid/Blood Leak	8	8
Product Quality Problem	7	7
Device Contamination with Chemical or Other Material	7	7
Delivered as Unsterile Product	6	6
Material Protrusion/Extrusion	5	5
Break	4	4
Physical Resistance/Sticking	4	4
Volume Accuracy Problem	3	3
Incorrect, Inadequate or Imprecise Result or Readings	3	3
Material Discolored	3	3
Component Missing	3	3
Fitting Problem	1	1
Separation Problem	1	1
Device Damaged Prior to Use	1	1
Complete Blockage	1	1
Material Puncture/Hole	1	1
Unsealed Device Packaging	1	1
Defective Component	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Integrity Problem	1	1
Difficult to Insert	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Material Deformation	1	1
Detachment of Device or Device Component	1	1
Fracture	1	1
Protective Measures Problem	1	1
Inaccurate Information	1	1
Shielding Failure	1	1
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	83	83
Needle Stick/Puncture	9	9
No Consequences Or Impact To Patient	4	4
Exposure to Body Fluids	1	1
Pain	1	1