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TPLC
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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
2018
180
180
2019
200
207
2020
202
202
2021
216
216
2022
96
96
2023
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
161
165
Disconnection
127
127
Dull, Blunt
99
99
Suction Problem
89
89
Suction Failure
84
84
Inflation Problem
68
68
Detachment of Device or Device Component
53
53
Material Fragmentation
50
50
Device Contamination with Chemical or Other Material
45
48
Fluid/Blood Leak
38
38
Burst Container or Vessel
28
28
Fracture
18
18
Component Missing
17
17
Difficult to Remove
15
15
Leak/Splash
15
15
Material Rupture
14
14
Fitting Problem
14
14
Crack
13
13
Material Split, Cut or Torn
13
13
Pressure Problem
12
12
Therapeutic or Diagnostic Output Failure
11
11
Improper or Incorrect Procedure or Method
10
10
Contamination /Decontamination Problem
10
10
Device Damaged Prior to Use
9
9
Entrapment of Device
9
9
Detachment Of Device Component
9
9
Incorrect Measurement
9
9
Physical Resistance/Sticking
9
9
Material Separation
8
8
Device Operates Differently Than Expected
8
8
Partial Blockage
7
7
Component Misassembled
7
7
Gas/Air Leak
6
6
Complete Blockage
6
6
Restricted Flow rate
5
5
Loose or Intermittent Connection
5
5
Misassembled
5
5
Delivered as Unsterile Product
5
5
Material Puncture/Hole
5
5
Obstruction of Flow
5
5
Tear, Rip or Hole in Device Packaging
5
5
Appropriate Term/Code Not Available
5
5
No Apparent Adverse Event
4
4
Insufficient Information
4
4
Difficult to Open or Close
4
4
Material Deformation
4
4
Material Twisted/Bent
4
4
Use of Device Problem
4
4
Difficult to Insert
4
4
Collapse
4
4
Deflation Problem
3
3
Deformation Due to Compressive Stress
3
3
No Flow
3
3
Output Problem
3
3
Packaging Problem
3
3
Device Fell
3
3
Torn Material
2
2
Noise, Audible
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Infusion or Flow Problem
2
2
Device Markings/Labelling Problem
2
2
Connection Problem
2
2
Defective Device
2
2
Structural Problem
2
2
Inadequacy of Device Shape and/or Size
2
2
Failure to Infuse
2
2
Unsealed Device Packaging
2
2
Nonstandard Device
2
2
Inadequate Instructions for Healthcare Professional
2
2
Contamination
2
2
Decrease in Suction
2
2
Unintended Ejection
1
1
Inaccurate Flow Rate
1
1
Component Falling
1
1
Material Frayed
1
1
Hole In Material
1
1
Migration or Expulsion of Device
1
1
No Device Output
1
1
Product Quality Problem
1
1
Out-Of-Box Failure
1
1
Insufficient Flow or Under Infusion
1
1
Device Slipped
1
1
Device Inoperable
1
1
Self-Activation or Keying
1
1
Failure to Advance
1
1
Split
1
1
Failure to Cut
1
1
Malposition of Device
1
1
Blocked Connection
1
1
Cut In Material
1
1
Contamination of Device Ingredient or Reagent
1
1
Device Contamination With Biological Material
1
1
Device Packaging Compromised
1
1
Device Contaminated During Manufacture or Shipping
1
1
Material Integrity Problem
1
1
Device Dislodged or Dislocated
1
1
Incorrect Device Or Component Shipped
1
1
No Pressure
1
1
Medical Gas Supply Problem
1
1
Scratched Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
347
347
No Known Impact Or Consequence To Patient
313
313
No Clinical Signs, Symptoms or Conditions
312
312
No Patient Involvement
112
115
Foreign Body In Patient
89
89
Insufficient Information
27
27
Device Embedded In Tissue or Plaque
24
24
No Information
21
25
No Code Available
12
12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
12
12
Patient Problem/Medical Problem
11
11
Hematoma
8
8
Unspecified Infection
6
6
Pain
6
6
Injury
3
3
Skin Irritation
2
2
Impaired Healing
2
2
Irritation
2
2
Bruise/Contusion
2
2
Fever
2
2
Tissue Damage
2
2
Test Result
1
1
Foreign Body Sensation in Eye
1
1
Edema
1
1
Vessel Or Plaque, Device Embedded In
1
1
Abdominal Pain
1
1
Abscess
1
1
Exposure to Body Fluids
1
1
Laceration(s)
1
1
Necrosis
1
1
Hemorrhage/Bleeding
1
1
Hemorrhage, Subdural
1
1
Failure of Implant
1
1
Blood Loss
1
1
Joint Laxity
1
1
Swelling
1
1
Sepsis
1
1
Fasciitis
1
1
Discomfort
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
COVIDIEN LLC
II
Dec-21-2018
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