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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
2020 76 76
2021 41 41
2022 77 79
2023 63 65
2024 102 102
2025 91 91

Device Problems MDRs with this Device Problem Events in those MDRs
Break 223 223
Fluid/Blood Leak 36 36
Contamination /Decontamination Problem 21 21
Leak/Splash 17 17
Difficult to Remove 16 17
Difficult to Advance 10 10
Detachment of Device or Device Component 10 10
Physical Resistance/Sticking 9 11
Material Fragmentation 8 8
Disconnection 7 7
Entrapment of Device 6 6
Material Separation 6 6
Fracture 5 5
Material Split, Cut or Torn 4 5
Loose or Intermittent Connection 4 4
Obstruction of Flow 4 4
Component Missing 4 4
No Flow 3 3
Nonstandard Device 3 3
Flushing Problem 3 3
Failure to Advance 3 3
Connection Problem 2 2
Appropriate Term/Code Not Available 2 2
Device Dislodged or Dislocated 2 2
Tear, Rip or Hole in Device Packaging 2 2
Product Quality Problem 2 2
Material Deformation 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Flow or Under Infusion 2 2
Unraveled Material 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Defective Device 2 2
Defective Component 2 2
Material Puncture/Hole 2 2
Crack 2 2
Output Problem 2 2
Mechanical Problem 2 2
Device Misassembled During Manufacturing /Shipping 1 1
Use of Device Problem 1 1
Difficult to Insert 1 1
Patient Device Interaction Problem 1 1
Gas/Air Leak 1 1
Material Twisted/Bent 1 1
Failure to Deliver 1 1
Deflation Problem 1 1
Lack of Effect 1 1
Inflation Problem 1 1
Misconnection 1 1
Positioning Problem 1 1
Inadequacy of Device Shape and/or Size 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 176 179
Foreign Body In Patient 151 151
No Consequences Or Impact To Patient 27 27
Pain 23 23
Insufficient Information 18 19
No Known Impact Or Consequence To Patient 16 16
Needle Stick/Puncture 14 14
Device Embedded In Tissue or Plaque 9 9
Inadequate Pain Relief 8 8
No Information 6 6
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
Disability 1 1
Skin Inflammation/ Irritation 1 1
Hematoma 1 1
Reaction to Medicinal Component of Device 1 1
Injury 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1

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