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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device 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 CodeCBT
Regulation Number 868.1100
Device Class 1

MDR Year MDR Reports MDR Events
2014 6 6
2015 10 10
2016 30 30
2017 22 22
2018 15 15
2019 19 19
2020 10 10
2021 24 24
2022 13 13
2023 13 13
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 28 28
Detachment Of Device Component 19 19
Disconnection 17 17
Leak/Splash 16 16
Fluid/Blood Leak 15 15
Break 9 9
Mechanical Problem 9 9
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Component Missing 8 8
Material Integrity Problem 6 6
Contamination 6 6
Display or Visual Feedback Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Device Operates Differently Than Expected 4 4
Filling Problem 4 4
Defective Device 4 4
Appropriate Term/Code Not Available 3 3
Protective Measures Problem 3 3
Material Separation 3 3
Contamination /Decontamination Problem 3 3
Gas/Air Leak 3 3
Air Leak 3 3
Loose or Intermittent Connection 2 2
Coagulation in Device or Device Ingredient 2 2
Device Contamination with Chemical or Other Material 2 2
Excess Flow or Over-Infusion 2 2
Use of Device Problem 2 2
No Pressure 2 2
Air/Gas in Device 2 2
Burst Container or Vessel 2 2
Material Fragmentation 1 1
Obstruction of Flow 1 1
False Reading From Device Non-Compliance 1 1
Out-Of-Box Failure 1 1
Infusion or Flow Problem 1 1
Packaging Problem 1 1
Misconnection 1 1
Failure to Prime 1 1
High Readings 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Unsealed Device Packaging 1 1
Failure to Advance 1 1
Defective Component 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Dislodged or Dislocated 1 1
Crack 1 1
Reflux within Device 1 1
Nonstandard Device 1 1
Output Problem 1 1
Migration or Expulsion of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 57 57
No Clinical Signs, Symptoms or Conditions 48 48
No Known Impact Or Consequence To Patient 48 48
Needle Stick/Puncture 12 12
Hemorrhage/Bleeding 8 8
Blood Loss 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Information 4 4
Insufficient Information 4 4
No Code Available 3 3
Unspecified Infection 1 1
Venipuncture 1 1
Foreign Body In Patient 1 1
Exposure to Body Fluids 1 1
No Patient Involvement 1 1
Fluid Discharge 1 1
Thrombus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health II Sep-02-2016
2 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
3 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
4 SunMed Holdings, LLC II Sep-23-2022
5 Vyaire Medical II Aug-28-2017
6 Westmed Inc II Oct-20-2012
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