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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
2017 78 78
2018 100 100
2019 66 66
2020 113 113
2021 36 36
2022 88 88
2023 55 55
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 89 89
Loss of or Failure to Bond 85 85
Fluid/Blood Leak 82 82
Migration or Expulsion of Device 50 50
Break 49 49
Material Separation 33 33
Unraveled Material 27 27
Detachment of Device or Device Component 26 26
Crack 25 25
Defective Device 21 21
Difficult to Remove 19 19
Fracture 15 15
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
Device Operates Differently Than Expected 5 5
Material Deformation 5 5
Material Twisted/Bent 5 5
Difficult to Advance 5 5
Packaging Problem 4 4
Physical Resistance/Sticking 4 4
Detachment Of Device Component 4 4
Material Frayed 3 3
Contamination /Decontamination Problem 3 3
Material Split, Cut or Torn 3 3
Material Integrity Problem 3 3
Device Dislodged or Dislocated 2 2
Device Contamination with Chemical or Other Material 2 2
Material Too Rigid or Stiff 2 2
Device-Device Incompatibility 2 2
Tear, Rip or Hole in Device Packaging 2 2
Use of Device Problem 2 2
Hole In Material 2 2
Bent 2 2
Occlusion Within Device 2 2
Disconnection 2 2
Entrapment of Device 1 1
Material Fragmentation 1 1
Disassembly 1 1
Peeled/Delaminated 1 1
Material Puncture/Hole 1 1
Difficult to Insert 1 1
Delivered as Unsterile Product 1 1
Suction Problem 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Component Missing 1 1
Incomplete or Missing Packaging 1 1
Retraction Problem 1 1
Sticking 1 1
Stretched 1 1
Failure to Advance 1 1
Split 1 1
Patient-Device Incompatibility 1 1
Activation, Positioning or Separation Problem 1 1
Device Damaged by Another Device 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 Consequences Or Impact To Patient 148 148
No Clinical Signs, Symptoms or Conditions 136 136
No Known Impact Or Consequence To Patient 90 90
No Patient Involvement 50 50
Irritation 50 50
Foreign Body In Patient 27 27
Insufficient Information 14 14
No Code Available 10 10
Awareness during Anaesthesia 7 7
Low Blood Pressure/ Hypotension 6 6
Device Embedded In Tissue or Plaque 6 6
No Information 5 5
Hemorrhage/Bleeding 3 3
Failure of Implant 2 2
Unspecified Infection 2 2
Seroma 2 2
Laceration(s) 2 2
Discomfort 2 2
Inadequate Pain Relief 2 2
Perforation of Vessels 2 2
Low Oxygen Saturation 2 2
Blood Loss 2 2
Pseudoaneurysm 1 1
Great Vessel Perforation 1 1
Coma 1 1
Cough 1 1
Respiratory Arrest 1 1
Blister 1 1
Skin Inflammation/ Irritation 1 1
Swelling/ Edema 1 1
Internal Organ Perforation 1 1
Pain 1 1
Tachycardia 1 1
Ventricular Fibrillation 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Hyperventilation 1 1
Cardiac Arrest 1 1
Death 1 1
Dyspnea 1 1
Air Embolism 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II May-30-2018
2 Cook Inc. II Jun-13-2019
3 Cook Inc. II Mar-02-2017
4 Galt Medical Corporation II Dec-14-2020
5 Galt Medical Corporation II Jul-27-2018
6 Micromedics, Inc. II Apr-12-2017
7 Vascular Solutions, Inc. II Jun-18-2018
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