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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device nerve block tray
Regulation Description Anesthesia conduction 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 CodeOGJ
Regulation Number 868.5140
Device Class 2

MDR Year MDR Reports MDR Events
2016 2 2
2017 1 1
2018 4 4
2019 2 2
2020 6 6
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination /Decontamination Problem 6 6
Break 5 5
Device Contaminated During Manufacture or Shipping 2 2
Device Contamination with Chemical or Other Material 1 1
Material Puncture/Hole 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 5 5
No Known Impact Or Consequence To Patient 3 3
Foreign Body In Patient 3 3
Device Embedded In Tissue or Plaque 2 2
No Patient Involvement 2 2
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Avid Medical, Inc. II Mar-19-2020
2 Medical Action Industries, Inc. 306 I May-12-2021
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