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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 77
2023 63 63
2024 102 102
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 172 172
Fluid/Blood Leak 32 32
Difficult to Remove 16 16
Leak/Splash 16 16
Contamination /Decontamination Problem 14 14
Difficult to Advance 8 8
Material Fragmentation 7 7
Detachment of Device or Device Component 7 7
Disconnection 7 7
Physical Resistance/Sticking 6 6
Entrapment of Device 5 5
Fracture 4 4
Obstruction of Flow 4 4
Loose or Intermittent Connection 4 4
Failure to Advance 3 3
Flushing Problem 3 3
Material Separation 3 3
Material Split, Cut or Torn 3 3
No Flow 3 3
Component Missing 3 3
Material Deformation 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Appropriate Term/Code Not Available 2 2
Product Quality Problem 2 2
Insufficient Flow or Under Infusion 2 2
Defective Component 2 2
Output Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Crack 2 2
Nonstandard Device 2 2
Protective Measures Problem 1 1
Connection Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Dislodged or Dislocated 1 1
Material Twisted/Bent 1 1
Malposition of Device 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Defective Device 1 1
Complete Blockage 1 1
Difficult to Insert 1 1
Misconnection 1 1
Deflation Problem 1 1
Material Disintegration 1 1
Material Frayed 1 1
Wrong Label 1 1
Naturally Worn 1 1
Inflation Problem 1 1
Positioning Problem 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 135 135
Foreign Body In Patient 118 118
No Consequences Or Impact To Patient 27 27
Pain 21 21
No Known Impact Or Consequence To Patient 16 16
Insufficient Information 13 13
Needle Stick/Puncture 10 10
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
Cardiac Arrest 2 2
Cerebrospinal Fluid Leakage 2 2
Paresthesia 2 2
Discomfort 2 2
Numbness 2 2
Perforation 2 2
Headache 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Injury 1 1
Disability 1 1
Skin Inflammation/ Irritation 1 1
Reaction to Medicinal Component of Device 1 1

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