TPLC - Total Product Life Cycle

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Device	indicator, physical/chemical sterilization process
Regulation Description	Sterilization process indicator.
Product Code	JOJ
Regulation Number	880.2800
Device Class	2

Premarket Reviews
Manufacturer	Decision
3M COMPANY
	GRANTED	1
	SUBSTANTIALLY EQUIVALENT	7
ADVANCED STERILIZATION PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ANDERSEN STERILIZERS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CROSSTEX INTERNATIONAL, INC. (A CANTEL MEDICAL COMPANY)
	SUBSTANTIALLY EQUIVALENT	1
JIANGMEN NEW ERA EXTERNAL USE DRUG CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
KEM MEDICAL PRODUCTS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
PROPPER MANUFACTURING CO., INC.
	SUBSTANTIALLY EQUIVALENT	5
SERIM RESEARCH
	SUBSTANTIALLY EQUIVALENT	1
SERIM RESEARCH CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
STERIS
	SUBSTANTIALLY EQUIVALENT	6
STERIS CORPARATION
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	5
STERITEC PRODUCTS MFG CO INC
	SUBSTANTIALLY EQUIVALENT	1
STERITEC PRODUCTS MFG. (A GETINGE GROUP COMPANY)
	SUBSTANTIALLY EQUIVALENT	1
STERITEC PRODUCTS, INC. (A GETINGE COMPANY)
	SUBSTANTIALLY EQUIVALENT	1
TERRAGENE SA
	SUBSTANTIALLY EQUIVALENT	1
TRUE INDICATING LLC
	SUBSTANTIALLY EQUIVALENT	2
TRUE INDICATING, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unexpected Color	23	23
Fluid/Blood Leak	13	13
Appropriate Term/Code Not Available	12	12
Material Integrity Problem	11	11
Leak/Splash	8	8
Material Discolored	7	7
Product Quality Problem	5	5
Problem with Sterilization	5	5
Explosion	4	4
Insufficient Information	4	4
Use of Device Problem	4	4
Contamination /Decontamination Problem	4	4
Improper Chemical Reaction	3	3
Device Reprocessing Problem	3	3
No Apparent Adverse Event	3	3
Defective Device	3	3
Defective Component	3	3
Output Problem	3	3
Therapeutic or Diagnostic Output Failure	2	2
Packaging Problem	2	2
Material Separation	2	2
Burst Container or Vessel	2	2
Contamination	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Material Fragmentation	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Device Damaged by Another Device	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Material Rupture	1	1
Material Deformation	1	1
Device Handling Problem	1	1
Device Damaged Prior to Use	1	1
Peeled/Delaminated	1	1
Detachment of Device or Device Component	1	1
Illegible Information	1	1
Missing Information	1	1
Protective Measures Problem	1	1
Material Split, Cut or Torn	1	1
Device Ingredient or Reagent Problem	1	1
Nonstandard Device	1	1
Optical Discoloration	1	1
Activation, Positioning or Separation Problem	1	1
Loss of or Failure to Bond	1	1
Device Slipped	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	95	95
Insufficient Information	25	25
No Known Impact Or Consequence To Patient	2	2
Foreign Body In Patient	1	1
No Patient Involvement	1	1
Hemorrhage/Bleeding	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	3M Company - Health Care Business	II	May-18-2023
2	Mckesson Medical-Surgical Inc. Corporate Office	III	Sep-26-2022
3	Resource Optimization & Innovation LLC	II	Jul-24-2020
4	Steris Corporation Hopkins Facility	III	Sep-10-2022
5	TERRAGENE S.A.	II	Jan-26-2024
6	Young Dental Mfg Co I LLC	II	Feb-02-2022