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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 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 230 230
Break 161 161
Fluid/Blood Leak 64 64
Leak/Splash 18 18
Difficult to Remove 15 15
Obstruction of Flow 12 12
Contamination /Decontamination Problem 11 11
Physical Resistance/Sticking 9 9
Loose or Intermittent Connection 8 8
Entrapment of Device 7 7
Disconnection 7 7
Failure to Advance 7 7
Difficult to Advance 7 7
Material Split, Cut or Torn 6 6
Fracture 6 6
Material Fragmentation 5 5
Material Separation 5 5
Infusion or Flow Problem 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
Tear, Rip or Hole in Device Packaging 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Deformation 1 1
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
Naturally Worn 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Protective Measures Problem 1 1
Unintended Movement 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 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
No Consequences Or Impact To Patient 111 111
Foreign Body In Patient 107 107
No Known Impact Or Consequence To Patient 92 92
No Clinical Signs, Symptoms or Conditions 88 88
Device Embedded In Tissue or Plaque 17 17
Pain 13 13
Needle Stick/Puncture 11 11
Insufficient Information 7 7
Cerebrospinal Fluid Leakage 4 4
Inadequate Pain Relief 4 4
Hematoma 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Perforation 3 3
Headache 3 3
No Patient Involvement 3 3
Cardiac Arrest 2 2
Discomfort 2 2
Numbness 2 2
Congestive Heart Failure 1 1
Arachnoiditis, Spinal 1 1
Abscess 1 1
Injury 1 1
Patient Problem/Medical Problem 1 1
Disability 1 1
Hemorrhage/Bleeding 1 1
Skin Inflammation/ Irritation 1 1
Weakness 1 1
Meningitis 1 1
Neck Stiffness 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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