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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
Product CodeGAB
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 30 30
2020 26 26
2021 17 139
2022 17 17
2023 32 32
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Break 66 66
Fracture 26 26
Device Contaminated During Manufacture or Shipping 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Material Fragmentation 5 5
Detachment of Device or Device Component 3 3
Device Fell 2 2
Insufficient Information 2 2
Delivered as Unsterile Product 2 2
Material Puncture/Hole 2 2
Material Protrusion/Extrusion 2 2
Material Twisted/Bent 2 2
Entrapment of Device 2 2
Component Missing 2 2
Device Contamination with Body Fluid 1 1
Tear, Rip or Hole in Device Packaging 1 1
Material Integrity Problem 1 1
Product Quality Problem 1 1
Material Separation 1 1
Device Slipped 1 1
Peeled/Delaminated 1 1
Appropriate Term/Code Not Available 1 1
Therapeutic or Diagnostic Output Failure 1 123
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 51 51
Foreign Body In Patient 21 21
No Known Impact Or Consequence To Patient 21 21
Wound Dehiscence 9 9
Device Embedded In Tissue or Plaque 8 8
Needle Stick/Puncture 4 4
Insufficient Information 4 4
Pain 3 3
No Patient Involvement 2 2
No Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 124
Patient Problem/Medical Problem 1 1
No Code Available 1 1
Failure to Anastomose 1 1
Organ Dehiscence 1 1
No Consequences Or Impact To Patient 1 1
Discharge 1 1
Numbness 1 1
Abscess 1 1
Bacterial Infection 1 1
Bruise/Contusion 1 1
Unspecified Infection 1 1

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