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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 16
2021 6 6
2022 22 22
2023 23 23
2024 71 71
2025 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Break 43 45
Leak/Splash 26 26
Appropriate Term/Code Not Available 25 25
Material Integrity Problem 13 13
Fluid/Blood Leak 10 10
Obstruction of Flow 8 8
Mechanical Problem 5 5
Material Fragmentation 5 5
Contamination 5 5
Insufficient Information 5 5
Difficult to Advance 3 3
Defective Device 3 5
Material Too Soft/Flexible 2 2
Connection Problem 2 2
Detachment of Device or Device Component 2 2
Material Deformation 2 2
Contamination /Decontamination Problem 2 2
Material Puncture/Hole 2 2
Crack 2 2
Physical Resistance/Sticking 2 2
Output Problem 2 2
Device Slipped 2 2
Defective Component 1 1
Positioning Problem 1 1
Difficult to Remove 1 1
Difficult to Flush 1 1
Stretched 1 1
Fail-Safe Problem 1 1
Use of Device Problem 1 1
Incomplete or Inadequate Connection 1 1
Particulates 1 1
Infusion or Flow Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Device Handling Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Failure to Advance 1 1
Entrapment of Device 1 3
Flushing Problem 1 1
Component or Accessory Incompatibility 1 1
Loose or Intermittent Connection 1 1
Device Displays Incorrect Message 1 1
Disconnection 1 1
Failure to Seal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 85 85
Foreign Body In Patient 35 35
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Needle Stick/Puncture 11 11
Insufficient Information 9 9
Headache 8 8
Pain 7 7
No Information 6 6
No Consequences Or Impact To Patient 4 4
Device Embedded In Tissue or Plaque 3 5
Inadequate Pain Relief 2 2
Low Blood Pressure/ Hypotension 2 2
Failure of Implant 1 1
Muscle Weakness 1 1
Abrasion 1 1
No Known Impact Or Consequence To Patient 1 1
Osteomyelitis 1 1
Nerve Damage 1 1
Discomfort 1 1
Spinal Arachnoiditis 1 1
Dyspnea 1 1
Laceration(s) 1 1
Therapeutic Response, Decreased 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B. Braun Medical, Inc. II Jan-24-2025
2 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
3 MEDLINE INDUSTRIES, LP - Northfield II Mar-25-2025
4 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
5 MEDLINE INDUSTRIES, LP - Northfield II Nov-22-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Aug-27-2024
9 MEDLINE INDUSTRIES, LP - Northfield I Aug-08-2024
10 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
11 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
12 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
13 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
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