TPLC - Total Product Life Cycle

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Device	arterial blood sampling kit
Regulation Description	Arterial blood sampling 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	CBT
Regulation Number	868.1100
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	17	17
Detachment of Device or Device Component	12	12
Mechanical Problem	9	9
Air/Gas in Device	6	6
Leak/Splash	5	5
Break	4	4
Crack	4	4
Filling Problem	4	4
Contamination	4	4
Fitting Problem	3	3
Insufficient Information	3	3
Defective Device	3	3
Material Integrity Problem	3	3
Component Missing	3	3
Failure to Seal	3	3
No Pressure	2	2
Protective Measures Problem	2	2
Disconnection	1	1
Burst Container or Vessel	1	1
Output Problem	1	1
Unsealed Device Packaging	1	1
Defective Component	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Material Fragmentation	1	1
Fail-Safe Problem	1	1
Use of Device Problem	1	1
Infusion or Flow Problem	1	1
Material Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	72	72
Insufficient Information	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Needle Stick/Puncture	4	4
Exposure to Body Fluids	3	3
Hemorrhage/Bleeding	3	3
Foreign Body In Patient	1	1
Fluid Discharge	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-03-2023
2	MEDLINE INDUSTRIES, LP - Northfield	II	Jul-20-2023
3	SunMed Holdings, LLC	II	Sep-23-2022