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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessories, catheter
Product CodeKGZ
Regulation Number 878.4200
Device Class 1

MDR Year MDR Reports MDR Events
2019 66 66
2020 113 113
2021 36 36
2022 88 88
2023 55 55
2024 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 69 69
Fluid/Blood Leak 66 66
Migration or Expulsion of Device 50 50
Loss of or Failure to Bond 33 33
Material Separation 29 29
Detachment of Device or Device Component 25 25
Break 25 25
Unraveled Material 25 25
Defective Device 20 20
Crack 13 13
Difficult to Remove 10 10
Adverse Event Without Identified Device or Use Problem 8 8
Device Contaminated During Manufacture or Shipping 6 6
Unsealed Device Packaging 6 6
Degraded 5 5
Material Deformation 5 5
Difficult to Advance 5 5
Material Twisted/Bent 5 5
Physical Resistance/Sticking 4 4
Fracture 4 4
Material Integrity Problem 3 3
Contamination /Decontamination Problem 3 3
Material Split, Cut or Torn 3 3
Device-Device Incompatibility 2 2
Disconnection 2 2
Material Too Rigid or Stiff 2 2
Use of Device Problem 2 2
Device Damaged Prior to Use 1 1
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1
Peeled/Delaminated 1 1
Material Puncture/Hole 1 1
Entrapment of Device 1 1
Difficult to Insert 1 1
Delivered as Unsterile Product 1 1
Activation, Positioning or Separation Problem 1 1
Device Damaged by Another Device 1 1
Patient-Device Incompatibility 1 1
Stretched 1 1
Device Dislodged or Dislocated 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Migration 1 1
Program or Algorithm Execution Problem 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 143 143
No Consequences Or Impact To Patient 78 78
Irritation 50 50
No Known Impact Or Consequence To Patient 26 26
Foreign Body In Patient 25 25
No Patient Involvement 17 17
Insufficient Information 16 16
Awareness during Anaesthesia 7 7
Low Blood Pressure/ Hypotension 6 6
Hemorrhage/Bleeding 4 4
Device Embedded In Tissue or Plaque 4 4
No Code Available 2 2
Low Oxygen Saturation 2 2
Discomfort 2 2
Inadequate Pain Relief 2 2
Failure of Implant 2 2
Unspecified Infection 2 2
Laceration(s) 2 2
Seroma 2 2
Perforation of Vessels 2 2
Great Vessel Perforation 1 1
Tachycardia 1 1
Ventricular Fibrillation 1 1
Internal Organ Perforation 1 1
Pain 1 1
Cardiac Arrest 1 1
Dyspnea 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Hyperventilation 1 1
Coma 1 1
Blood Loss 1 1
Pseudoaneurysm 1 1
Air Embolism 1 1
Cough 1 1
Respiratory Arrest 1 1
Blister 1 1
Skin Inflammation/ Irritation 1 1
Swelling/ Edema 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II Jun-13-2019
2 Galt Medical Corporation II Dec-14-2020
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