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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
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
2018 4 4
2019 2 2
2020 6 6
2021 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6 6
Contamination /Decontamination Problem 6 6
Device Contamination with Chemical or Other Material 1 1
Material Puncture/Hole 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 4 4
No Consequences Or Impact To Patient 3 3
No Patient Involvement 2 2
No Known Impact Or Consequence To Patient 2 2
Device Embedded In Tissue or Plaque 2 2
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Avid Medical, Inc. II Mar-19-2020
2 Busse Hospital Disposables, Inc. II Nov-29-2022
3 Busse Hospital Disposables, Inc. II May-28-2022
4 Medical Action Industries, Inc. 306 I May-12-2021
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