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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
Regulation Description Anesthesia conduction catheter.
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
2021 13 14
2022 13 16
2023 19 19
2024 28 28
2025 19 19
2026 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Break 49 50
Contamination /Decontamination Problem 6 6
Unexpected Therapeutic Results 3 3
Difficult to Advance 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 44 46
No Clinical Signs, Symptoms or Conditions 30 32
Insufficient Information 9 9
Pain 6 6
Inadequate Pain Relief 4 4
Cramp(s) /Muscle Spasm(s) 3 3
Needle Stick/Puncture 2 2
Discomfort 2 2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2
Numbness 1 1
Alteration in Body Temperature 1 1
Laceration(s) 1 1
Cerebrospinal Fluid Leakage 1 1
Headache 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B Braun Medical Inc I Jun-03-2026
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