TPLC - Total Product Life Cycle

• Device: cesarean section tray
• Definition: This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
• Product Code: OHM
• Regulation Number: 884.1720
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2018	2	2
2019	10	10
2020	8	8
2021	3	3
2022	3	3
2023	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Component Missing	5	5
Device Contamination with Chemical or Other Material	5	5
Break	4	4
Material Split, Cut or Torn	2	2
Delivered as Unsterile Product	2	2
Defective Device	2	2
Contamination /Decontamination Problem	1	1
Detachment of Device or Device Component	1	1
Material Separation	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Packaging Problem	1	1
Detachment Of Device Component	1	1
Component Falling	1	1
Decrease in Suction	1	1
Fluid/Blood Leak	1	1
Material Fragmentation	1	1
Device Contamination with Body Fluid	1	1
Tear, Rip or Hole in Device Packaging	1	1
Failure to Cut	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	10	10
No Clinical Signs, Symptoms or Conditions	6	6
Insufficient Information	6	6
Foreign Body In Patient	2	2
No Code Available	1	1
No Patient Involvement	1	1
No Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	American Contract Systems	II	May-29-2020
2	American Contract Systems, Inc.	II	Sep-08-2022
3	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-06-2023
4	ROi CPS LLC	II	Apr-25-2023
5	ROi CPS LLC	II	Jul-19-2022
6	ROi CPS LLC	II	Apr-26-2022