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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
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 19 19
Fluid/Blood Leak 13 13
Leak/Splash 12 12
Mechanical Problem 9 9
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Material Integrity Problem 5 5
Break 5 5
Filling Problem 4 4
Contamination 4 4
Disconnection 3 3
Defective Device 3 3
Contamination /Decontamination Problem 3 3
Gas/Air Leak 3 3
No Pressure 2 2
Improper or Incorrect Procedure or Method 2 2
Air/Gas in Device 2 2
Component Missing 2 2
Use of Device Problem 2 2
Protective Measures Problem 2 2
Appropriate Term/Code Not Available 2 2
Coagulation in Device or Device Ingredient 2 2
Defective Component 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unsealed Device Packaging 1 1
Infusion or Flow Problem 1 1
Material Separation 1 1
Device Contamination with Chemical or Other Material 1 1
Material Fragmentation 1 1
Output Problem 1 1
Burst Container or Vessel 1 1
Obstruction of Flow 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 48 48
No Known Impact Or Consequence To Patient 23 23
No Consequences Or Impact To Patient 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Insufficient Information 4 4
Hemorrhage/Bleeding 3 3
No Information 2 2
Blood Loss 2 2
Needle Stick/Puncture 2 2
Unspecified Infection 1 1
No Code Available 1 1
Foreign Body In Patient 1 1
Exposure to Body Fluids 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
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