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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device neurological tray
Definition This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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 CodeOJG
Regulation Number 882.4525
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2017 1 1
2018 7 7
2019 3 3
2020 8 8
2021 9 9
2022 11 11
2023 9 9
2024 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 10 10
Contamination 8 8
Break 8 8
Material Separation 6 6
Material Fragmentation 5 5
Material Frayed 3 3
Contamination /Decontamination Problem 3 3
Component Incompatible 3 3
Detachment of Device or Device Component 3 3
Device Contamination with Chemical or Other Material 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Material Integrity Problem 3 3
Delivered as Unsterile Product 2 2
Incomplete or Missing Packaging 2 2
Crack 2 2
Filling Problem 1 1
Fire 1 1
Flaked 1 1
Inaccurate Flow Rate 1 1
Loose or Intermittent Connection 1 1
Nonstandard Device 1 1
Connection Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Product Quality Problem 1 1
Packaging Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Damaged by Another Device 1 1
Unexpected Color 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 38 38
Insufficient Information 8 8
No Known Impact Or Consequence To Patient 8 8
Foreign Body In Patient 5 5
No Consequences Or Impact To Patient 5 5
Local Reaction 3 3
No Information 1 1
Sleep Dysfunction 1 1
No Patient Involvement 1 1
Burn(s) 1 1
Dyspnea 1 1
Headache 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 American Contract Systems, Inc. II Jan-26-2024
3 American Contract Systems, Inc. II Sep-08-2022
4 American Contract Systems, Inc. II May-06-2022
5 Avid Medical, Inc. II Mar-19-2020
6 Cardinal Health 200, LLC II Oct-10-2023
7 Customed, Inc II Apr-14-2016
8 Customed, Inc II Sep-03-2015
9 Customed, Inc I Dec-16-2014
10 Customed, Inc I Aug-29-2014
11 Integra LifeSciences Corp. II Mar-22-2022
12 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
13 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
14 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
15 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
16 Medline Industries Inc II Dec-10-2021
17 ROi CPS LLC II Apr-25-2023
18 ROi CPS LLC II Nov-23-2022
19 Stradis Medical, LLC dba Stradis Healthcare II Apr-04-2022
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