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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
2021 1 1
2022 1 1
2024 6 6
2025 9 9
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination 3 3
Leak/Splash 2 2
Break 2 2
Obstruction of Flow 2 2
Mechanical Problem 1 1
Physical Resistance/Sticking 1 1
Material Puncture/Hole 1 1
Insufficient Information 1 1
Defective Device 1 1
Contamination /Decontamination Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Material Deformation 1 1
Device Contamination with Chemical or Other Material 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14 14
Insufficient Information 2 2
Foreign Body In Patient 1 1
Osteomyelitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Busse Hospital Disposables, Inc. II Nov-29-2022
2 Busse Hospital Disposables, Inc. II May-28-2022
3 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
4 MEDLINE INDUSTRIES, LP - Northfield II Nov-22-2024
5 MEDLINE INDUSTRIES, LP - Northfield II Aug-27-2024
6 MEDLINE INDUSTRIES, LP - Northfield I Aug-08-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
8 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
9 Medical Action Industries, Inc. 306 I May-12-2021
10 Medline Industries, LP II Feb-17-2026
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