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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device 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 kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Product CodeOGE
Regulation Number 868.5120
Device Class 2

MDR Year MDR Reports MDR Events
2021 41 41
2022 77 79
2023 63 65
2024 102 102
2025 98 98
2026 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Break 202 202
Contamination /Decontamination Problem 20 20
Fluid/Blood Leak 18 18
Difficult to Remove 15 16
Leak/Splash 14 14
Detachment of Device or Device Component 11 11
Physical Resistance/Sticking 9 11
Material Split, Cut or Torn 8 9
Difficult to Advance 8 8
Material Separation 7 7
Material Fragmentation 6 6
Entrapment of Device 6 6
Disconnection 6 6
Material Puncture/Hole 3 3
Nonstandard Device 3 3
Flushing Problem 3 3
Loose or Intermittent Connection 3 3
Fracture 3 3
Unraveled Material 3 3
Component Missing 3 3
Obstruction of Flow 3 3
Crack 2 2
Device Markings/Labelling Problem 2 2
Connection Problem 2 2
Output Problem 2 2
Defective Component 2 2
Defective Device 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Appropriate Term/Code Not Available 2 2
Mechanical Problem 2 2
Material Frayed 2 2
Material Twisted/Bent 2 2
Insufficient Flow or Under Infusion 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Product Quality Problem 2 2
Material Deformation 2 2
Naturally Worn 1 1
Protective Measures Problem 1 1
Device Dislodged or Dislocated 1 1
Failure to Advance 1 1
Migration 1 1
Tear, Rip or Hole in Device Packaging 1 1
Inadequacy of Device Shape and/or Size 1 1
Labelling, Instructions for Use or Training Problem 1 1
Misconnection 1 1
Inflation Problem 1 1
Lack of Effect 1 1
Excess Flow or Over-Infusion 1 1
Gas/Air Leak 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 189 192
Foreign Body In Patient 142 142
Pain 21 21
Insufficient Information 18 19
Needle Stick/Puncture 12 12
Inadequate Pain Relief 8 8
Device Embedded In Tissue or Plaque 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Perforation 2 2
Cardiac Arrest 2 2
Paresthesia 2 2
Discomfort 2 2
Numbness 2 2
Cerebrospinal Fluid Leakage 2 2
Emotional Changes 1 1
Fetal Distress 1 1
Skin Inflammation/ Irritation 1 1
Reaction to Medicinal Component of Device 1 1
Foreign Body Embolism 1 1
Awareness during Anaesthesia 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B BRAUN MEDICAL INC II Oct-09-2025
2 B Braun Medical Inc II May-29-2026
3 B. Braun Medical, Inc. II Feb-16-2024
4 B. Braun Medical, Inc. II Sep-21-2023
5 B. Braun Medical, Inc. II Jun-23-2023
6 MEDLINE INDUSTRIES, LP - Northfield II Nov-22-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Aug-27-2024
9 Medline Industries, LP I May-28-2026
10 Medline Industries, LP II Apr-30-2026
11 Pajunk Medical Systems, L.P. II Nov-23-2022
12 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
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