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TPLC
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Device
needle, catheter
Regulation Description
Introduction/drainage catheter and accessories.
Product Code
GCB
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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