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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device obstetrical 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 CodeOKV
Regulation Number 884.4520
Device Class 2

MDR Year MDR Reports MDR Events
2017 3 3
2020 3 3
2021 1 1
2022 2 2
2023 1 1
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 3 3
Entrapment of Device 2 2
Fire 1 1
Moisture Damage 1 1
Component Missing 1 1
Connection Problem 1 1
Device Packaging Compromised 1 1
Device Contamination with Chemical or Other Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Appropriate Term/Code Not Available 1 1
Sharp Edges 1 1
Break 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 8
Airway Obstruction 1 1
Aspiration/Inhalation 1 1
Laceration(s) 1 1
No Consequences Or Impact To Patient 1 1
Nasal Obstruction 1 1
No Patient Involvement 1 1
No Known Impact Or Consequence To Patient 1 1
No Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Avid Medical, Inc. II Mar-19-2020
2 Avid Medical, Inc. II Apr-19-2017
3 Customed, Inc II Apr-14-2016
4 Customed, Inc II Sep-03-2015
5 Customed, Inc I Dec-16-2014
6 Customed, Inc I Aug-29-2014
7 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
9 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
10 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
11 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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