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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device spinal epidural 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 CodeOFT
Regulation Number 868.5120
Device Class 2

MDR Year MDR Reports MDR Events
2020 14 14
2021 6 6
2022 22 22
2023 23 23
2024 71 71
2025 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Break 37 37
Appropriate Term/Code Not Available 24 24
Leak/Splash 13 13
Material Integrity Problem 10 10
Obstruction of Flow 8 8
Material Fragmentation 5 5
Fluid/Blood Leak 5 5
Mechanical Problem 3 3
Difficult to Advance 3 3
Device Slipped 2 2
Output Problem 2 2
Insufficient Information 2 2
Contamination 2 2
Detachment of Device or Device Component 2 2
Device Contamination with Chemical or Other Material 2 2
Material Too Soft/Flexible 2 2
Disconnection 1 1
Component or Accessory Incompatibility 1 1
Entrapment of Device 1 1
Physical Resistance/Sticking 1 1
Incomplete or Inadequate Connection 1 1
Defective Component 1 1
Defective Device 1 1
Positioning Problem 1 1
Contamination /Decontamination Problem 1 1
Stretched 1 1
Fail-Safe Problem 1 1
Use of Device Problem 1 1
Infusion or Flow Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Material Deformation 1 1
Device Handling Problem 1 1
Flushing Problem 1 1
Connection Problem 1 1
Loose or Intermittent Connection 1 1
Device Displays Incorrect Message 1 1
Failure to Seal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 52 52
Foreign Body In Patient 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Needle Stick/Puncture 11 11
Headache 8 8
Insufficient Information 7 7
No Information 6 6
Pain 6 6
No Consequences Or Impact To Patient 4 4
Device Embedded In Tissue or Plaque 3 3
Inadequate Pain Relief 2 2
Failure of Implant 1 1
Muscle Weakness 1 1
Abrasion 1 1
No Known Impact Or Consequence To Patient 1 1
Nerve Damage 1 1
Spinal Arachnoiditis 1 1
Dyspnea 1 1
Laceration(s) 1 1
Therapeutic Response, Decreased 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B. Braun Medical, Inc. II Jan-24-2025
2 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Nov-22-2024
4 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
5 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Aug-27-2024
7 MEDLINE INDUSTRIES, LP - Northfield I Aug-08-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
9 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
10 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
11 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
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