TPLC - Total Product Life Cycle

• Device: tube, aspirating, flexible, connecting
• Product Code: BYY
• Regulation Number: 880.6740
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2014	3	3
2015	2	2
2016	20	20
2017	34	34
2018	12	12
2019	18	18
2020	23	23
2021	11	11
2022	11	11
2023	11	11

Device Problems	MDRs with this Device Problem	Events in those MDRs
Delivered as Unsterile Product	75	75
Device Packaging Compromised	21	21
Packaging Problem	19	19
Unsealed Device Packaging	13	13
Device Contamination with Chemical or Other Material	5	5
Detachment Of Device Component	2	2
Detachment of Device or Device Component	2	2
Material Integrity Problem	2	2
Contamination	1	1
Improper or Incorrect Procedure or Method	1	1
Tear, Rip or Hole in Device Packaging	1	1
Suction Failure	1	1
Material Twisted/Bent	1	1
Device Operates Differently Than Expected	1	1
Sparking	1	1
Insufficient Heating	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Connection Problem	1	1
Contamination /Decontamination Problem	1	1
Component Missing	1	1
Defective Device	1	1
Break	1	1
Decrease in Suction	1	1
Device Damaged Prior to Use	1	1
Kinked	1	1
Partial Blockage	1	1
Physical Resistance/Sticking	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	73	73
No Clinical Signs, Symptoms or Conditions	37	37
Not Applicable	21	21
No Known Impact Or Consequence To Patient	6	6
No Consequences Or Impact To Patient	5	5
No Information	1	1
Insufficient Information	1	1
Bacterial Infection	1	1
Dyspnea	1	1