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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device spinal 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 type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOFT
Regulation Number 868.5120
Device Class 2

MDR Year MDR Reports MDR Events
2019 20 20
2020 14 14
2021 6 6
2022 22 22
2023 23 23
2024 54 54

Device Problems MDRs with this Device Problem Events in those MDRs
Break 34 34
Appropriate Term/Code Not Available 19 19
Leak/Splash 12 12
Detachment of Device or Device Component 10 10
Material Integrity Problem 9 9
Obstruction of Flow 8 8
Material Fragmentation 6 6
Fluid/Blood Leak 5 5
Difficult to Advance 4 4
Mechanical Problem 3 3
Output Problem 2 2
Contamination 2 2
Material Too Soft/Flexible 2 2
Loose or Intermittent Connection 2 2
Device Slipped 2 2
Insufficient Information 2 2
Physical Resistance/Sticking 1 1
Incomplete or Inadequate Connection 1 1
Entrapment of Device 1 1
Contamination /Decontamination Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Connection Problem 1 1
Flushing Problem 1 1
Device Displays Incorrect Message 1 1
Component or Accessory Incompatibility 1 1
Disconnection 1 1
Defective Device 1 1
Positioning Problem 1 1
Defective Component 1 1
Fail-Safe Problem 1 1
Stretched 1 1
Use of Device Problem 1 1
Unintended Ejection 1 1
Infusion or Flow Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Material Rupture 1 1
Material Deformation 1 1
Device Handling Problem 1 1
Failure to Seal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 38 38
Foreign Body In Patient 27 27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
No Known Impact Or Consequence To Patient 12 12
Needle Stick/Puncture 12 12
Headache 8 8
No Information 6 6
Insufficient Information 6 6
Pain 6 6
No Consequences Or Impact To Patient 6 6
Device Embedded In Tissue or Plaque 3 3
Failure of Implant 1 1
No Code Available 1 1
Muscle Weakness 1 1
Abrasion 1 1
Nerve Damage 1 1
Spinal Arachnoiditis 1 1
Dyspnea 1 1
Laceration(s) 1 1
Therapeutic Response, Decreased 1 1
Inadequate Pain Relief 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B. Braun Medical, Inc. II Sep-05-2019
2 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Aug-27-2024
4 MEDLINE INDUSTRIES, LP - Northfield I Aug-08-2024
5 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
6 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
7 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
8 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
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