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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device connector, airway (extension)
Regulation Description Airway connector.
Product CodeBZA
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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