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TPLC
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Device
tubing, pressure and accessories
Regulation Description
Pressure tubing and accessories.
Product Code
BYX
Regulation Number
868.5860
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
32
32
2021
13
13
2022
10
10
2023
25
25
2024
25
25
2025
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Crack
20
20
Detachment of Device or Device Component
17
17
Peeled/Delaminated
9
9
Material Twisted/Bent
8
8
Connection Problem
6
6
Gas/Air Leak
6
6
Material Split, Cut or Torn
6
6
Adverse Event Without Identified Device or Use Problem
5
5
Corroded
4
4
Disconnection
4
4
Leak/Splash
3
3
Break
3
3
Difficult or Delayed Positioning
3
3
Device Dislodged or Dislocated
3
3
Positioning Failure
2
2
Loose or Intermittent Connection
2
2
Material Deformation
2
2
Unintended Ejection
2
2
Patient-Device Incompatibility
2
2
Component Missing
2
2
Burst Container or Vessel
2
2
Positioning Problem
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Fluid/Blood Leak
1
1
Fire
1
1
Moisture Damage
1
1
Misconnection
1
1
Obstruction of Flow
1
1
Patient Device Interaction Problem
1
1
Tidal Volume Fluctuations
1
1
Unintended Movement
1
1
No Flow
1
1
Device Damaged by Another Device
1
1
Failure to Deliver
1
1
Pressure Problem
1
1
Improper Flow or Infusion
1
1
Material Fragmentation
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
45
45
No Consequences Or Impact To Patient
27
27
Low Oxygen Saturation
12
12
Insufficient Information
7
7
Skin Tears
4
4
Pain
3
3
Aspiration/Inhalation
3
3
Numbness
3
3
Dyspnea
3
3
No Patient Involvement
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Cough
2
2
Fall
2
2
Headache
2
2
Hematoma
2
2
No Known Impact Or Consequence To Patient
1
1
Bradycardia
1
1
Paralysis
1
1
Bruise/Contusion
1
1
Airway Obstruction
1
1
Skin Inflammation/ Irritation
1
1
Superficial (First Degree) Burn
1
1
Chemical Exposure
1
1
Decreased Respiratory Rate
1
1
Cognitive Changes
1
1
Fatigue
1
1
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