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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device needle, catheter
Regulation Description Introduction/drainage catheter and accessories.
Product CodeGCB
Regulation Number 878.4200
Device Class 1

MDR Year MDR Reports MDR Events
2021 19 19
2022 23 23
2023 14 14
2024 7 7
2025 16 16
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 26 26
Fracture 19 19
Detachment of Device or Device Component 6 6
Break 5 5
Leak/Splash 4 4
Difficult to Advance 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Material Integrity Problem 3 3
Obstruction of Flow 2 2
Material Split, Cut or Torn 2 2
Crack 2 2
Physical Resistance/Sticking 1 1
Mechanical Jam 1 1
Material Fragmentation 1 1
Dull, Blunt 1 1
Difficult to Remove 1 1
Material Rupture 1 1
Peeled/Delaminated 1 1
Unraveled Material 1 1
Unsealed Device Packaging 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 50 50
Foreign Body In Patient 14 14
Insufficient Information 9 9
Hemorrhage/Blood Loss/Bleeding 2 2
Device Embedded In Tissue or Plaque 2 2
Abscess 2 2
Pneumothorax 2 2
Pleural Effusion 1 1
Pulmonary Edema 1 1
Liver Laceration(s) 1 1
Needle Stick/Puncture 1 1
No Consequences Or Impact To Patient 1 1
Hemothorax 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Incorporated II Apr-12-2024
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