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TPLC
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show TPLC since
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Device
connector, airway (extension)
Product Code
BZA
Regulation Number
868.5810
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
21
21
2021
15
15
2022
21
21
2023
39
39
2024
28
28
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Split, Cut or Torn
28
28
Crack
18
18
Gas/Air Leak
16
16
Break
14
14
Connection Problem
13
13
Material Separation
11
11
Disconnection
8
8
Leak/Splash
5
5
Defective Device
4
4
Fracture
4
4
Loose or Intermittent Connection
4
4
Mechanical Problem
3
3
Use of Device Problem
3
3
Detachment of Device or Device Component
3
3
Failure to Disconnect
3
3
Fitting Problem
2
2
Incomplete or Inadequate Connection
2
2
Defective Component
2
2
Degraded
2
2
Material Fragmentation
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
Material Integrity Problem
1
1
Component Missing
1
1
Material Twisted/Bent
1
1
Blocked Connection
1
1
Packaging Problem
1
1
Component Incompatible
1
1
Improper Chemical Reaction
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
85
85
No Consequences Or Impact To Patient
10
10
Insufficient Information
7
7
No Known Impact Or Consequence To Patient
5
5
Hypoventilation
4
4
Hypoxia
3
3
Low Oxygen Saturation
3
3
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
Asthma
1
1
Foreign Body In Patient
1
1
Vomiting
1
1
Tachycardia
1
1
Unspecified Tissue Injury
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
Oct-23-2024
4
Smiths Medical ASD Inc.
II
May-12-2023
5
Westmed, Inc.
II
Oct-30-2024
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