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TPLC
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show TPLC since
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Device
apparatus, suction, single patient use, portable, nonpowered
Product Code
GCY
Regulation Number
878.4680
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
200
207
2020
202
202
2021
216
216
2022
96
96
2023
92
92
2024
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
130
134
Disconnection
115
115
Dull, Blunt
102
102
Suction Failure
93
93
Detachment of Device or Device Component
58
58
Material Fragmentation
54
54
Suction Problem
51
51
Device Contamination with Chemical or Other Material
47
50
Inflation Problem
47
47
Fluid/Blood Leak
34
34
Burst Container or Vessel
20
20
Fracture
16
16
Fitting Problem
16
16
Leak/Splash
15
15
Material Split, Cut or Torn
15
15
Difficult to Remove
13
13
Component Missing
13
13
Material Rupture
12
12
Pressure Problem
11
11
Therapeutic or Diagnostic Output Failure
11
11
Product Quality Problem
10
10
Improper or Incorrect Procedure or Method
10
10
Entrapment of Device
10
10
Crack
10
10
Incorrect Measurement
9
9
Material Separation
8
8
Decrease in Suction
8
8
Contamination /Decontamination Problem
8
8
Device Damaged Prior to Use
8
8
Physical Resistance/Sticking
7
7
Component Misassembled
7
7
Tear, Rip or Hole in Device Packaging
6
6
Gas/Air Leak
6
6
Partial Blockage
6
6
Restricted Flow rate
5
5
Defective Device
5
5
Material Twisted/Bent
4
4
Complete Blockage
4
4
Use of Device Problem
4
4
Material Puncture/Hole
4
4
Misassembled
4
4
Delivered as Unsterile Product
4
4
Difficult to Insert
4
4
No Apparent Adverse Event
4
4
Insufficient Information
3
3
Appropriate Term/Code Not Available
3
3
Device Fell
3
3
Loose or Intermittent Connection
3
3
Collapse
3
3
Output Problem
3
3
Material Deformation
3
3
Difficult to Open or Close
3
3
Obstruction of Flow
3
3
Structural Problem
2
2
Failure to Infuse
2
2
Deformation Due to Compressive Stress
2
2
Connection Problem
2
2
Device Markings/Labelling Problem
2
2
Packaging Problem
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Inadequate Instructions for Healthcare Professional
2
2
Unsealed Device Packaging
2
2
Inadequacy of Device Shape and/or Size
2
2
Device Contaminated During Manufacture or Shipping
2
2
Missing Information
1
1
Explosion
1
1
Material Too Soft/Flexible
1
1
Noise, Audible
1
1
Self-Activation or Keying
1
1
Decrease in Pressure
1
1
Contamination
1
1
Backflow
1
1
Deflation Problem
1
1
Inaccurate Flow Rate
1
1
Unintended Ejection
1
1
Material Frayed
1
1
No Pressure
1
1
No Flow
1
1
Scratched Material
1
1
Device Dislodged or Dislocated
1
1
Material Integrity Problem
1
1
Infusion or Flow Problem
1
1
Contamination of Device Ingredient or Reagent
1
1
Malposition of Device
1
1
Biocompatibility
1
1
Failure to Advance
1
1
Defective Component
1
1
Insufficient Flow or Under Infusion
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
369
369
No Consequences Or Impact To Patient
275
275
No Known Impact Or Consequence To Patient
200
200
Foreign Body In Patient
81
81
No Patient Involvement
65
68
Insufficient Information
29
29
Device Embedded In Tissue or Plaque
21
21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
15
15
Exposure to Body Fluids
12
12
Unspecified Infection
11
11
Patient Problem/Medical Problem
11
11
Hematoma
8
8
Post Operative Wound Infection
7
7
No Information
6
10
Pain
5
5
No Code Available
4
4
Injury
3
3
Irritation
2
2
Laceration(s)
2
2
Bruise/Contusion
2
2
Unspecified Tissue Injury
2
2
Fever
1
1
Foreign Body Sensation in Eye
1
1
Hemorrhage/Bleeding
1
1
Hypersensitivity/Allergic reaction
1
1
Failure of Implant
1
1
Abdominal Pain
1
1
Abscess
1
1
Pneumothorax
1
1
Skin Irritation
1
1
Tissue Damage
1
1
Impaired Healing
1
1
Discomfort
1
1
Blood Loss
1
1
Fluid Discharge
1
1
Joint Laxity
1
1
Skin Inflammation/ Irritation
1
1
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