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 Code	OFU
Regulation Number	868.5120
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	49	50
Contamination /Decontamination Problem	5	5
Therapeutic or Diagnostic Output Failure	4	6
Material Discolored	3	3
Defective Device	2	2
Detachment of Device or Device Component	2	3
Device Contaminated During Manufacture or Shipping	1	1
Output Problem	1	1
Difficult to Advance	1	1
Patient Device Interaction Problem	1	1
Material Fragmentation	1	1
Insufficient Flow or Under Infusion	1	1
Fracture	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Foreign Body In Patient	40	42
No Clinical Signs, Symptoms or Conditions	29	31
Insufficient Information	6	6
Pain	6	6
Inadequate Pain Relief	4	4
Cramp(s) /Muscle Spasm(s)	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Needle Stick/Puncture	2	2
Discomfort	2	2
Cerebrospinal Fluid Leakage	1	1
Headache	1	1
Numbness	1	1
Device Embedded In Tissue or Plaque	1	1
Alteration in Body Temperature	1	1