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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device spinal anesthesia 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 CodeOFU
Regulation Number 868.5120
Device Class 2

MDR Year MDR Reports MDR Events
2019 11 11
2020 6 6
2021 13 13
2022 13 13
2023 19 19
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 40 40
Contamination /Decontamination Problem 5 5
Material Discolored 3 3
Difficult to Advance 2 2
Therapeutic or Diagnostic Output Failure 2 2
Detachment of Device or Device Component 1 1
Material Deformation 1 1
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output Problem 1 1
Off-Label Use 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Advance 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 29 29
No Clinical Signs, Symptoms or Conditions 16 16
No Known Impact Or Consequence To Patient 6 6
Inadequate Pain Relief 3 3
Pain 3 3
Needle Stick/Puncture 3 3
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Consequences Or Impact To Patient 1 1
Discomfort 1 1
Cerebrospinal Fluid Leakage 1 1
Headache 1 1
Numbness 1 1
Alteration in Body Temperature 1 1

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