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TPLC
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Device
connector, airway (extension)
Regulation Description
Airway connector.
Product Code
BZA
Regulation Number
868.5810
Device Class
1
MDR Year
MDR Reports
MDR Events
2021
15
15
2022
21
22
2023
38
38
2024
28
28
2025
25
25
2026
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Split, Cut or Torn
28
28
Crack
22
22
Connection Problem
18
18
Gas/Air Leak
18
18
Fracture
13
13
Material Puncture/Hole
11
11
Material Separation
11
11
Disconnection
9
9
Loose or Intermittent Connection
5
5
Degraded
4
4
Leak/Splash
4
4
Use of Device Problem
3
3
Failure to Disconnect
3
3
Defective Device
3
3
Mechanical Problem
3
3
Fitting Problem
2
2
Defective Component
2
2
Detachment of Device or Device Component
2
2
Incomplete or Inadequate Connection
2
2
Break
2
2
Misconnection
2
2
Device Damaged Prior to Use
1
2
Component Missing
1
1
Failure to Deliver
1
1
Inaccurate Delivery
1
1
High Readings
1
1
Blocked Connection
1
1
Device Contaminated During Manufacture or Shipping
1
1
Material Integrity Problem
1
1
Material Twisted/Bent
1
1
Packaging Problem
1
1
Insufficient Device Problem Information
1
1
Appropriate Device Problem Term/Code Not Available
1
1
Misassembled During Installation
1
1
Loss of or Failure to Bond
1
1
Material Disintegration
1
1
Gas Output Problem
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
100
101
Insufficient Information
7
7
Hypoventilation
6
6
Hypoxia
4
4
Low Oxygen Saturation
4
4
Unspecified Respiratory Problem
2
2
Asthma
2
2
Low Blood Pressure/ Hypotension
2
2
Nausea
1
1
Cancer
1
1
Tachycardia
1
1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
1
1
Brain Injury
1
1
Headache
1
1
Unintended Extubation
1
1
Vomiting
1
1
Unspecified Tissue Injury
1
1
Dizziness
1
1
No Consequences Or Impact To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Draeger, Inc.
I
Dec-08-2025
2
Smiths Medical ASD Inc.
II
Oct-23-2024
3
Smiths Medical ASD Inc.
II
May-12-2023
4
Westmed, Inc.
II
Oct-30-2024
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