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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device apparatus, suction, single patient use, portable, nonpowered
Product CodeGCY
Regulation Number 878.4680
Device Class 1

MDR Year MDR Reports MDR Events
2017 260 260
2018 180 180
2019 200 207
2020 202 202
2021 216 216
2022 68 68

Device Problems MDRs with this Device Problem Events in those MDRs
Break 213 217
Suction Problem 148 148
Disconnection 141 141
Dull, Blunt 100 100
Inflation Problem 95 95
Suction Failure 82 82
Detachment of Device or Device Component 54 54
Device Contamination with Chemical or Other Material 52 55
Material Fragmentation 49 49
Fluid Leak 44 44
Detachment Of Device Component 33 33
Burst Container or Vessel 30 30
Leak/Splash 24 24
Component Missing 21 21
Fracture 20 20
Difficult to Remove 19 19
Crack 18 18
Device Operates Differently Than Expected 17 17
Fitting Problem 14 14
Pressure Problem 13 13
Material Rupture 13 13
Improper or Incorrect Procedure or Method 12 12
Contamination /Decontamination Problem 11 11
Therapeutic or Diagnostic Output Failure 11 11
Material Split, Cut or Torn 11 11
Device Damaged Prior to Use 10 10
Aspiration Issue 10 10
Material Separation 10 10
Air Leak 9 9
Physical Resistance/Sticking 9 9
Entrapment of Device 9 9
Decrease in Suction 8 8
Incorrect Measurement 8 8
Complete Blockage 8 8
Partial Blockage 7 7
Loose or Intermittent Connection 7 7
Delivered as Unsterile Product 6 6
Component Misassembled 6 6
Gas Leak 6 6
Connection Problem 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Misassembled 5 5
Material Puncture/Hole 5 5
Appropriate Term/Code Not Available 5 5
Difficult to Open or Close 4 4
Torn Material 4 4
No Apparent Adverse Event 4 4
Insufficient Information 4 4
Use of Device Problem 4 4
No Flow 4 4
Obstruction of Flow 4 4
Collapse 4 4
Difficult to Insert 4 4
Material Twisted/Bent 4 4
Tear, Rip or Hole in Device Packaging 4 4
Material Deformation 4 4
Material Integrity Problem 3 3
Failure to Infuse 3 3
Device Fell 3 3
Device Inoperable 3 3
Restricted Flow rate 3 3
Deflation Problem 3 3
Device Slipped 3 3
Output Problem 3 3
Packaging Problem 3 3
Physical Property Issue 3 3
Deformation Due to Compressive Stress 3 3
Noise, Audible 3 3
Device Dislodged or Dislocated 2 2
Defective Device 2 2
Structural Problem 2 2
Split 2 2
Nonstandard Device 2 2
Component Falling 2 2
Occlusion Within Device 2 2
Device Markings/Labelling Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Contamination 2 2
Device Contaminated During Manufacture or Shipping 2 2
Device Contamination With Biological Material 2 2
Infusion or Flow Problem 2 2
Bent 2 2
Out-Of-Box Failure 2 2
Physical Resistance 2 2
Unsealed Device Packaging 2 2
Off-Label Use 1 1
Migration or Expulsion of Device 1 1
Material Too Rigid or Stiff 1 1
Device Reprocessing Problem 1 1
Hole In Material 1 1
Device Packaging Compromised 1 1
Incorrect Device Or Component Shipped 1 1
Medical Gas Supply Problem 1 1
No Pressure 1 1
Missing Information 1 1
Inaccurate Flow Rate 1 1
Peeled/Delaminated 1 1
Decrease in Pressure 1 1
Product Quality Problem 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 454 454
No Consequences Or Impact To Patient 376 376
No Clinical Signs, Symptoms or Conditions 281 281
No Patient Involvement 126 129
Foreign Body In Patient 102 102
No Information 52 56
Device Embedded In Tissue or Plaque 30 30
Insufficient Information 26 26
No Code Available 25 25
Patient Problem/Medical Problem 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Hematoma 9 9
Unspecified Infection 9 9
Pain 6 6
Injury 4 4
Impaired Healing 2 2
Sepsis 2 2
Skin Irritation 2 2
Swelling 2 2
Irritation 2 2
Abscess 2 2
Bruise/Contusion 2 2
Edema 2 2
Fever 2 2
Tissue Damage 2 2
Joint Laxity 1 1
Test Result 1 1
Foreign Body Sensation in Eye 1 1
Arthritis 1 1
Exposure to Body Fluids 1 1
Wound Dehiscence 1 1
Vessel Or Plaque, Device Embedded In 1 1
Abdominal Pain 1 1
Laceration(s) 1 1
Nausea 1 1
Necrosis 1 1
Hemorrhage/Bleeding 1 1
Hemorrhage, Subdural 1 1
Failure of Implant 1 1
Thrombus 1 1
Staphylococcus Aureus 1 1
Discomfort 1 1
Meningitis 1 1
Chemical Exposure 1 1
Blood Loss 1 1
Fasciitis 1 1
Fluid Discharge 1 1

Recalls
Manufacturer Recall Class Date Posted
1 COVIDIEN LLC II Dec-21-2018
2 Cardinal Health 200, LLC II May-23-2017
3 Stryker Leibinger GmbH & Co. KG II Feb-08-2017
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