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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
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Split, Cut or Torn
28
28
Crack
22
22
Gas/Air Leak
18
18
Connection Problem
18
18
Fracture
13
13
Material Puncture/Hole
11
11
Material Separation
11
11
Disconnection
9
9
Break
7
7
Loose or Intermittent Connection
5
5
Leak/Splash
4
4
Degraded
4
4
Fitting Problem
3
3
Mechanical Problem
3
3
Defective Device
3
3
Use of Device Problem
3
3
Detachment of Device or Device Component
3
3
Failure to Disconnect
3
3
Incomplete or Inadequate Connection
2
2
Defective Component
2
2
Misconnection
2
2
Device Contaminated During Manufacture or Shipping
1
1
Output Problem
1
1
Device Damaged Prior to Use
1
2
Material Disintegration
1
1
Separation Failure
1
1
Insufficient Information
1
1
Material Integrity Problem
1
1
Failure to Deliver
1
1
Misassembled During Installation
1
1
Component Missing
1
1
Material Twisted/Bent
1
1
Blocked Connection
1
1
Packaging Problem
1
1
Labelling, Instructions for Use or Training Problem
1
1
Inaccurate Delivery
1
1
Appropriate Term/Code Not Available
1
1
Component Incompatible
1
1
Gas Output Problem
1
1
Loss of or Failure to Bond
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
99
100
Hypoventilation
6
6
Insufficient Information
6
6
Hypoxia
4
4
Low Oxygen Saturation
4
4
Asthma
2
2
Unspecified Respiratory Problem
2
2
Low Blood Pressure/ Hypotension
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Brain Injury
1
1
Nausea
1
1
Dizziness
1
1
Vomiting
1
1
Tachycardia
1
1
Unspecified Tissue Injury
1
1
No Consequences Or Impact To Patient
1
1
Headache
1
1
Cancer
1
1
Unintended Extubation
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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