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TPLC
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Device
apparatus, suction, single patient use, portable, nonpowered
Regulation Description
Nonpowered, single patient, portable suction apparatus.
Product Code
GCY
Regulation Number
878.4680
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
202
202
2021
216
216
2022
96
96
2023
92
92
2024
75
75
2025
32
32
Device Problems
MDRs with this Device Problem
Events in those MDRs
Disconnection
106
106
Dull, Blunt
106
106
Suction Failure
85
85
Break
69
69
Material Fragmentation
61
61
Device Contamination with Chemical or Other Material
55
55
Inflation Problem
30
30
Fluid/Blood Leak
26
26
Detachment of Device or Device Component
24
24
Suction Problem
24
24
Material Split, Cut or Torn
20
20
Component Missing
16
16
Fracture
14
14
Burst Container or Vessel
11
11
Difficult to Remove
11
11
Fitting Problem
11
11
Entrapment of Device
10
10
Component Misassembled
10
10
Product Quality Problem
10
10
Leak/Splash
10
10
Crack
9
9
Pressure Problem
9
9
Incorrect Measurement
9
9
Decrease in Suction
8
8
Therapeutic or Diagnostic Output Failure
7
7
Tear, Rip or Hole in Device Packaging
7
7
Material Separation
7
7
Contamination /Decontamination Problem
6
6
Material Rupture
6
6
Physical Resistance/Sticking
5
5
Unsealed Device Packaging
5
5
Partial Blockage
5
5
Device Damaged Prior to Use
4
4
No Apparent Adverse Event
4
4
Defective Device
4
4
Device Contaminated During Manufacture or Shipping
4
4
Difficult to Insert
4
4
Restricted Flow rate
3
3
Output Problem
3
3
Insufficient Information
3
3
Material Twisted/Bent
3
3
Deformation Due to Compressive Stress
2
2
Difficult to Open or Close
2
2
Failure to Infuse
2
2
Delivered as Unsterile Product
2
2
Misassembled
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Obstruction of Flow
2
2
Use of Device Problem
2
2
Inadequate Instructions for Healthcare Professional
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
452
452
No Consequences Or Impact To Patient
166
166
No Known Impact Or Consequence To Patient
80
80
Foreign Body In Patient
63
63
Insufficient Information
31
31
No Patient Involvement
28
28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
20
20
Exposure to Body Fluids
14
14
Unspecified Infection
11
11
Device Embedded In Tissue or Plaque
10
10
Hematoma
9
9
Post Operative Wound Infection
8
8
Patient Problem/Medical Problem
5
5
No Code Available
3
3
Injury
3
3
Pain
3
3
Irritation
2
2
Laceration(s)
2
2
Abscess
2
2
Unspecified Tissue Injury
2
2
Bruise/Contusion
2
2
Impaired Healing
1
1
Wound Dehiscence
1
1
Hypersensitivity/Allergic reaction
1
1
Pneumothorax
1
1
Failure of Implant
1
1
Skin Irritation
1
1
No Information
1
1
Skin Inflammation/ Irritation
1
1
Inflammation
1
1
Anemia
1
1
Purulent Discharge
1
1
Blood Loss
1
1
Cellulitis
1
1
Seroma
1
1
Discomfort
1
1
Fluid Discharge
1
1
Joint Laxity
1
1
Hemorrhage/Bleeding
1
1
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