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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tray, surgical, needle
Product CodeFSH
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 4 4
2020 2 2
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Component Misassembled 3 3
Unsealed Device Packaging 2 2
Tear, Rip or Hole in Device Packaging 2 2
Contamination 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 5 5
No Clinical Signs, Symptoms or Conditions 2 2
Needle Stick/Puncture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
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