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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 4 4

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 15 15
Fluid/Blood Leak 11 11
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Component Missing 8 8
Mechanical Problem 8 8
Break 7 7
Contamination 6 6
Material Integrity Problem 6 6
Device Operates Differently Than Expected 4 4
Defective Device 4 4
Improper or Incorrect Procedure or Method 4 4
Display or Visual Feedback Problem 4 4
Filling Problem 4 4
Air Leak 3 3
Material Separation 3 3
Contamination /Decontamination Problem 3 3
Gas/Air Leak 3 3
Protective Measures Problem 3 3
Appropriate Term/Code Not Available 3 3
Air/Gas in Device 2 2
Device Contamination with Chemical or Other Material 2 2
No Pressure 2 2
Use of Device Problem 2 2
Burst Container or Vessel 2 2
Coagulation in Device or Device Ingredient 2 2
Excess Flow or Over-Infusion 2 2
Loose or Intermittent Connection 2 2
Migration or Expulsion of Device 1 1
Misconnection 1 1
Nonstandard Device 1 1
Unsealed Device Packaging 1 1
Failure to Prime 1 1
Reflux within Device 1 1
Crack 1 1
False Reading From Device Non-Compliance 1 1
Fitting Problem 1 1
Defective Component 1 1
Out-Of-Box Failure 1 1
Device Contamination with Body Fluid 1 1
Obstruction of Flow 1 1
High Readings 1 1
Failure to Advance 1 1
Output Problem 1 1
Packaging Problem 1 1
Device Dislodged or Dislocated 1 1
Therapeutic or Diagnostic Output Failure 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 57 57
No Known Impact Or Consequence To Patient 48 48
No Clinical Signs, Symptoms or Conditions 40 40
Needle Stick/Puncture 11 11
Hemorrhage/Bleeding 8 8
Blood Loss 5 5
No Information 4 4
Insufficient Information 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Code Available 3 3
Exposure to Body Fluids 1 1
No Patient Involvement 1 1
Fluid Discharge 1 1
Foreign Body In Patient 1 1
Unspecified Infection 1 1
Thrombus 1 1
Venipuncture 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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