TPLC - Total Product Life Cycle

• Device: system, transport, aerobic
• Product Code: JTW
• Regulation Number: 866.2900
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2019	8	8
2020	12	12
2021	7	7
2022	5	5
2023	23	23
2024	14	14

Device Problems	MDRs with this Device Problem	Events in those MDRs
Short Fill	13	13
Leak/Splash	11	11
Device Contamination with Chemical or Other Material	8	8
Incorrect, Inadequate or Imprecise Result or Readings	7	7
Device Markings/Labelling Problem	5	5
Volume Accuracy Problem	4	4
Device Ingredient or Reagent Problem	3	3
Delivered as Unsterile Product	3	3
Product Quality Problem	3	3
Adverse Event Without Identified Device or Use Problem	2	2
No Apparent Adverse Event	2	2
Separation Problem	2	2
Premature Separation	1	1
Missing Information	1	1
Insufficient Information	1	1
Material Protrusion/Extrusion	1	1
Naturally Worn	1	1
Component Missing	1	1
Detachment of Device or Device Component	1	1
Break	1	1
Contamination	1	1
Material Separation	1	1
Use of Device Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	47	47
No Known Impact Or Consequence To Patient	12	12
No Information	2	2
No Consequences Or Impact To Patient	2	2
Needle Stick/Puncture	1	1
Blood Loss	1	1
No Patient Involvement	1	1
Hemorrhage/Bleeding	1	1
Hypersensitivity/Allergic reaction	1	1
Failure of Implant	1	1
Inflammation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Hologic, Inc	II	Mar-11-2022
2	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022