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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device needle, suturing, disposable
Regulation Description Manual surgical instrument for general use.
Product CodeGAB
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 26 26
2021 17 139
2022 17 17
2023 32 32
2024 26 26
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 65 65
Fracture 30 30
Device Contaminated During Manufacture or Shipping 6 6
Material Fragmentation 5 5
Detachment of Device or Device Component 3 3
Entrapment of Device 2 2
Device Fell 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Protrusion/Extrusion 2 2
Separation Problem 1 1
Device Contamination with Body Fluid 1 1
Unintended Movement 1 1
Unsealed Device Packaging 1 1
Material Integrity Problem 1 1
Therapeutic or Diagnostic Output Failure 1 123
Component Missing 1 1
Delivered as Unsterile Product 1 1
Tear, Rip or Hole in Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 69 69
Foreign Body In Patient 24 24
No Known Impact Or Consequence To Patient 11 11
Device Embedded In Tissue or Plaque 7 7
Insufficient Information 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 124
Needle Stick/Puncture 2 2
Pain 2 2
Wound Dehiscence 1 1
No Information 1 1
Numbness 1 1
Bacterial Infection 1 1
No Consequences Or Impact To Patient 1 1
Bruise/Contusion 1 1

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