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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
2020 72 72
2021 19 19
2022 23 23
2023 14 14
2024 7 7
2025 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 30 30
Leak/Splash 22 22
Break 19 19
Fracture 19 19
Detachment of Device or Device Component 18 18
Material Split, Cut or Torn 9 9
Adverse Event Without Identified Device or Use Problem 6 6
Difficult to Remove 5 5
Nonstandard Device 3 3
Tear, Rip or Hole in Device Packaging 3 3
Material Rupture 3 3
Device Fell 3 3
Defective Component 2 2
Defective Device 2 2
Obstruction of Flow 2 2
Material Deformation 2 2
Crack 2 2
Entrapment of Device 2 2
Device Contaminated During Manufacture or Shipping 2 2
Mechanical Jam 2 2
Unsealed Device Packaging 1 1
Contamination 1 1
Material Fragmentation 1 1
Difficult to Insert 1 1
Unraveled Material 1 1
Use of Device Problem 1 1
Component Missing 1 1
Material Twisted/Bent 1 1
Structural Problem 1 1
Difficult to Advance 1 1
Device Markings/Labelling Problem 1 1
Packaging Problem 1 1
Product Quality Problem 1 1
Peeled/Delaminated 1 1
Inadequacy of Device Shape and/or Size 1 1
Physical Resistance/Sticking 1 1
Failure to Advance 1 1
Appropriate Term/Code Not Available 1 1
Suction Problem 1 1
Fluid/Blood Leak 1 1
Dull, Blunt 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 47 47
No Known Impact Or Consequence To Patient 24 24
Foreign Body In Patient 21 21
No Consequences Or Impact To Patient 19 19
Device Embedded In Tissue or Plaque 10 10
Insufficient Information 9 9
Pneumothorax 7 7
No Patient Involvement 5 5
Needle Stick/Puncture 2 2
Hemorrhage/Bleeding 2 2
Unspecified Infection 1 1
Exposure to Body Fluids 1 1
Pleural Effusion 1 1
Pulmonary Edema 1 1
Hemothorax 1 1
Liver Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Argon Medical Devices, Inc II May-22-2020
2 Becton Dickinson & Company II Apr-24-2020
3 Cook Incorporated II Apr-12-2024
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