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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
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
2019 341 341
2020 76 76
2021 41 41
2022 77 77
2023 63 63
2024 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 231 231
Break 169 169
Fluid/Blood Leak 64 64
Leak/Splash 18 18
Difficult to Remove 15 15
Obstruction of Flow 12 12
Contamination /Decontamination Problem 12 12
Physical Resistance/Sticking 9 9
Difficult to Advance 8 8
Loose or Intermittent Connection 8 8
Entrapment of Device 7 7
Disconnection 7 7
Failure to Advance 7 7
Fracture 6 6
Material Split, Cut or Torn 6 6
Infusion or Flow Problem 5 5
Material Fragmentation 5 5
Material Separation 5 5
Activation, Positioning or Separation Problem 4 4
No Flow 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Nonstandard Device 3 3
Insufficient Flow or Under Infusion 3 3
Component Missing 3 3
Crack 3 3
Flushing Problem 3 3
Complete Blockage 2 2
Defective Device 2 2
Malposition of Device 2 2
Defective Component 2 2
Product Quality Problem 2 2
Output Problem 2 2
Positioning Problem 2 2
Appropriate Term/Code Not Available 2 2
Tear, Rip or Hole in Device Packaging 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Deformation 2 2
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
Naturally Worn 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Patient Device Interaction Problem 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Protective Measures Problem 1 1
Unintended Movement 1 1
Wrong Label 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Slipped 1 1
Patient-Device Incompatibility 1 1
Failure to Deliver 1 1
Connection Problem 1 1
Material Disintegration 1 1
Material Frayed 1 1
Inflation Problem 1 1
Difficult to Insert 1 1
Mechanical Problem 1 1
Misconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 144 144
Foreign Body In Patient 114 114
No Consequences Or Impact To Patient 111 111
No Clinical Signs, Symptoms or Conditions 99 99
No Known Impact Or Consequence To Patient 92 92
Pain 19 19
Device Embedded In Tissue or Plaque 17 17
Needle Stick/Puncture 11 11
Insufficient Information 9 9
Inadequate Pain Relief 6 6
Cerebrospinal Fluid Leakage 5 5
Perforation 3 3
Headache 3 3
Hematoma 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Patient Involvement 3 3
Cardiac Arrest 2 2
Numbness 2 2
Discomfort 2 2
Injury 1 1
Disability 1 1
Neck Stiffness 1 1
Meningitis 1 1
Arachnoiditis, Spinal 1 1
Abscess 1 1
Congestive Heart Failure 1 1
Hemorrhage/Bleeding 1 1
Weakness 1 1
Patient Problem/Medical Problem 1 1
Paresthesia 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 Pajunk Medical Systems, L.P. II Nov-23-2022
5 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
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