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TPLC
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show TPLC since
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2024
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Device
tube, bronchial (w/wo connector)
Product Code
BTS
Regulation Number
868.5720
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
122
122
2020
91
91
2021
110
110
2022
140
140
2023
162
162
2024
34
34
Device Problems
MDRs with this Device Problem
Events in those MDRs
Gas/Air Leak
250
250
Use of Device Problem
189
189
Material Split, Cut or Torn
43
43
Inflation Problem
32
32
Defective Component
24
24
Break
23
23
Leak/Splash
16
16
Material Separation
15
15
Material Rupture
14
14
Fluid/Blood Leak
13
13
Insufficient Information
10
10
Appropriate Term/Code Not Available
10
10
Obstruction of Flow
8
8
Detachment of Device or Device Component
7
7
Material Integrity Problem
7
7
Crack
6
6
Mechanical Problem
5
5
Human-Device Interface Problem
4
4
Installation-Related Problem
4
4
Device Damaged Prior to Use
4
4
Sharp Edges
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Material Deformation
3
3
Component Missing
3
3
Partial Blockage
3
3
Material Fragmentation
3
3
Nonstandard Device
2
2
Material Discolored
2
2
Physical Resistance/Sticking
2
2
Material Too Soft/Flexible
1
1
Disconnection
1
1
Fracture
1
1
Positioning Failure
1
1
Burst Container or Vessel
1
1
Complete Blockage
1
1
Peeled/Delaminated
1
1
Material Puncture/Hole
1
1
Tear, Rip or Hole in Device Packaging
1
1
Fitting Problem
1
1
Patient-Device Incompatibility
1
1
Ambient Noise Problem
1
1
Connection Problem
1
1
Contamination of Device Ingredient or Reagent
1
1
Adverse Event Without Identified Device or Use Problem
1
1
No Apparent Adverse Event
1
1
Device Markings/Labelling Problem
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
404
404
No Patient Involvement
109
109
No Consequences Or Impact To Patient
48
48
Unintended Extubation
42
42
Extubate
24
24
Insufficient Information
16
16
Low Oxygen Saturation
14
14
No Known Impact Or Consequence To Patient
8
8
Injury
6
6
Unspecified Tissue Injury
5
5
Tissue Breakdown
4
4
Pain
3
3
No Information
3
3
Hemorrhage/Bleeding
3
3
Hypoventilation
2
2
Pneumothorax
2
2
Blood Loss
2
2
Fistula
1
1
Dysphagia/ Odynophagia
1
1
Low Blood Pressure/ Hypotension
1
1
Therapeutic Response, Decreased
1
1
Laceration(s)
1
1
Sore Throat
1
1
Adult Respiratory Distress Syndrome
1
1
Ventilator Dependent
1
1
Perforation of Esophagus
1
1
Decreased Respiratory Rate
1
1
Foreign Body In Patient
1
1
Unintended Radiation Exposure
1
1
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