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TPLC
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show TPLC since
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2024
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Device
connector, airway (extension)
Product Code
BZA
Regulation Number
868.5810
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
13
13
2020
21
21
2021
15
15
2022
21
21
2023
39
39
2024
20
20
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Split, Cut or Torn
29
29
Gas/Air Leak
16
16
Break
14
14
Crack
14
14
Connection Problem
13
13
Material Separation
12
12
Leak/Splash
8
8
Disconnection
7
7
Loose or Intermittent Connection
5
5
Defective Device
4
4
Use of Device Problem
4
4
Detachment of Device or Device Component
4
4
Fracture
4
4
Mechanical Problem
3
3
Material Fragmentation
3
3
Component Incompatible
3
3
Failure to Disconnect
3
3
Fitting Problem
2
2
Incomplete or Inadequate Connection
2
2
Defective Component
2
2
Degraded
2
2
Misconnection
2
2
Device Contaminated During Manufacture or Shipping
1
1
Output Problem
1
1
Device Damaged Prior to Use
1
1
Material Disintegration
1
1
Material Puncture/Hole
1
1
Separation Failure
1
1
Failure to Transmit Record
1
1
Material Integrity Problem
1
1
Moisture Damage
1
1
Component Missing
1
1
Material Twisted/Bent
1
1
Blocked Connection
1
1
Packaging Problem
1
1
Device Handling Problem
1
1
Improper Chemical Reaction
1
1
Fluid/Blood Leak
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
77
77
No Consequences Or Impact To Patient
13
13
No Known Impact Or Consequence To Patient
11
11
Insufficient Information
7
7
Hypoventilation
4
4
Low Oxygen Saturation
4
4
Hypoxia
3
3
Foreign Body In Patient
2
2
Unspecified Respiratory Problem
2
2
Low Blood Pressure/ Hypotension
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Nausea
1
1
Brain Injury
1
1
Dizziness
1
1
Aspiration/Inhalation
1
1
Asthma
1
1
Vomiting
1
1
No Patient Involvement
1
1
Tachycardia
1
1
Unspecified Tissue Injury
1
1
Hyperventilation
1
1
Headache
1
1
Cancer
1
1
Unintended Extubation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Bioseal Corporation
II
Aug-13-2020
2
Intersurgical Inc
II
Jan-08-2020
3
Smiths Medical ASD Inc.
II
May-12-2023
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