TPLC - Total Product Life Cycle

• 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 Code: OFU
• 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	11	11

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	43	43
Contamination /Decontamination Problem	5	5
Material Discolored	3	3
Difficult to Advance	2	2
Therapeutic or Diagnostic Output Failure	2	2
Improper or Incorrect Procedure or Method	1	1
Off-Label Use	1	1
Output Problem	1	1
Defective Device	1	1
Material Twisted/Bent	1	1
Material Deformation	1	1
Failure to Advance	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Detachment of Device or Device Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Foreign Body In Patient	31	31
No Clinical Signs, Symptoms or Conditions	20	20
No Known Impact Or Consequence To Patient	6	6
Insufficient Information	4	4
Pain	4	4
Needle Stick/Puncture	3	3
Inadequate Pain Relief	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Discomfort	1	1
Alteration in Body Temperature	1	1
Numbness	1	1
Cerebrospinal Fluid Leakage	1	1
No Consequences Or Impact To Patient	1	1
Headache	1	1