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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device needle, aspiration and injection, reusable
Regulation Description Manual surgical instrument for general use.
Product CodeGDM
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2021 2 4
2022 3 3
2023 3 3
2024 5 5
2025 6 6
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6 6
Physical Resistance/Sticking 3 3
Material Fragmentation 3 3
Break 2 2
Mechanical Problem 1 1
Activation Problem 1 1
Difficult to Remove 1 1
Material Twisted/Bent 1 3
Inadequacy of Device Shape and/or Size 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 7 9
No Clinical Signs, Symptoms or Conditions 5 5
Pneumothorax 4 4
Hemorrhage/Bleeding 3 3
Air Embolism 2 2
Fibrosis 2 2
Respiratory Failure 2 2
Bronchospasm 1 1
Foreign Body In Patient 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Cancer 1 1
Syncope/Fainting 1 1
Pericarditis 1 1
Pleural Empyema 1 1
Septic Shock 1 1
Vomiting 1 1
Cardiac Tamponade 1 1
Sore Throat 1 1
Respiratory Tract Infection 1 1
Needle Stick/Puncture 1 1
Cellulitis 1 1
Dyspnea 1 1
Fever 1 1
Headache 1 1
Hemoptysis 1 1
Hypoxia 1 1
Unspecified Infection 1 1
Pneumonia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Spiggle & Theis Mt Gmbh II Aug-15-2025
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