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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

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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