TPLC - Total Product Life Cycle

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Device	cardiac catheterization kit
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	OES
Regulation Number	870.1200
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	24	24
Break	20	20
Crack	19	19
Appropriate Term/Code Not Available	15	15
Connection Problem	13	13
Unraveled Material	7	7
Material Fragmentation	7	7
Material Frayed	7	7
Leak/Splash	7	7
Contamination /Decontamination Problem	7	7
Device Contamination with Chemical or Other Material	6	6
Physical Resistance/Sticking	6	6
Failure to Advance	6	6
Tear, Rip or Hole in Device Packaging	5	5
Material Deformation	5	5
Packaging Problem	4	4
Material Separation	4	4
Contamination	4	4
Fluid/Blood Leak	4	4
Difficult to Insert	3	3
Material Puncture/Hole	3	3
Obstruction of Flow	3	3
Component Missing	3	3
Activation, Positioning or Separation Problem	3	3
Detachment of Device or Device Component	3	3
Material Split, Cut or Torn	3	3
Air/Gas in Device	2	2
Insufficient Information	2	2
Device Markings/Labelling Problem	2	2
Difficult to Advance	2	2
Retraction Problem	2	2
Deformation Due to Compressive Stress	2	2
Stretched	2	2
Unexpected Therapeutic Results	1	1
Product Quality Problem	1	1
Difficult to Remove	1	1
Melted	1	1
Particulates	1	1
Peeled/Delaminated	1	1
Degraded	1	1
Difficult or Delayed Positioning	1	1
Burst Container or Vessel	1	1
Contamination of Device Ingredient or Reagent	1	1
Device Dislodged or Dislocated	1	1
Incomplete or Missing Packaging	1	1
Fitting Problem	1	1
Defective Component	1	1
Defective Device	1	1
Pressure Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Twisted/Bent	1	1
Mechanical Jam	1	1
Gas/Air Leak	1	1
Improper Flow or Infusion	1	1
Manufacturing, Packaging or Shipping Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	110	110
Insufficient Information	23	23
No Known Impact Or Consequence To Patient	12	12
No Consequences Or Impact To Patient	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
No Patient Involvement	6	6
Foreign Body In Patient	2	2
Exposure to Body Fluids	2	2
Death	1	1
Hemorrhage/Bleeding	1	1
Low Blood Pressure/ Hypotension	1	1
Obstruction/Occlusion	1	1
Needle Stick/Puncture	1	1
Underdose	1	1
Patient Problem/Medical Problem	1	1
Abrasion	1	1
Air Embolism	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	Jan-26-2024
3	American Contract Systems, Inc.	II	Oct-26-2023
4	American Contract Systems, Inc.	II	Sep-08-2022
5	American Contract Systems, Inc.	II	May-06-2022
6	Avid Medical, Inc.	II	Mar-19-2020
7	Centurion Medical Products Corporation	II	Oct-09-2019
8	MEDLINE INDUSTRIES, LP - Northfield	I	Feb-25-2024
9	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-03-2023
10	MEDLINE INDUSTRIES, LP - Northfield	II	Jul-20-2023
11	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-10-2023
12	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-06-2023
13	Merit Medical Systems, Inc.	II	Oct-01-2019
14	ROi CPS LLC	II	Apr-25-2023