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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
2021 6 6
2022 22 22
2023 23 23
2024 71 71
2025 57 57
2026 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Break 39 39
Appropriate Term/Code Not Available 25 25
Leak/Splash 24 24
Material Integrity Problem 13 13
Fluid/Blood Leak 9 9
Obstruction of Flow 9 9
Insufficient Information 6 6
Mechanical Problem 5 5
Connection Problem 5 5
Contamination 5 5
Material Fragmentation 5 5
Physical Resistance/Sticking 4 4
Difficult to Advance 3 3
Defective Device 3 3
Failure to Deliver 3 3
Material Too Soft/Flexible 2 2
Failure to Infuse 2 2
Detachment of Device or Device Component 2 2
Material Deformation 2 2
Material Twisted/Bent 2 2
Use of Device Problem 2 2
Contamination /Decontamination Problem 2 2
Material Puncture/Hole 2 2
Crack 2 2
Output Problem 2 2
Device Slipped 2 2
Stretched 1 1
Fail-Safe Problem 1 1
Difficult to Remove 1 1
Positioning Problem 1 1
Improper Flow or Infusion 1 1
Defective Component 1 1
Particulates 1 1
Infusion or Flow Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Lack of Effect 1 1
Device Handling Problem 1 1
Product Quality Problem 1 1
Difficult to Flush 1 1
Device Contamination with Chemical or Other Material 1 1
Failure to Advance 1 1
Incomplete or Inadequate Connection 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 98 98
Foreign Body In Patient 34 34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Insufficient Information 12 12
Needle Stick/Puncture 9 9
Headache 8 8
Pain 7 7
Inadequate Pain Relief 2 2
Low Blood Pressure/ Hypotension 2 2
Device Embedded In Tissue or Plaque 2 2
Failure of Implant 1 1
No Information 1 1
Muscle Weakness 1 1
Abrasion 1 1
Osteomyelitis 1 1
Nerve Damage 1 1
Discomfort 1 1
Spinal Arachnoiditis 1 1
Dyspnea 1 1
Laceration(s) 1 1
No Consequences Or Impact To Patient 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
14 Medline Industries, LP II Feb-17-2026
15 Medline Industries, LP II Jan-28-2026
16 Medline Industries, LP II Nov-14-2025
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