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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
2020 21 21
2021 15 15
2022 21 21
2023 39 39
2024 28 28
2025 3 3

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
Connection Problem 16 16
Break 14 14
Material Separation 11 11
Disconnection 8 8
Leak/Splash 5 5
Defective Device 4 4
Degraded 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
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
Appropriate Term/Code Not Available 1 1
Component Incompatible 1 1
Improper Chemical Reaction 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 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
Low Oxygen Saturation 4 4
Asthma 3 3
Hypoxia 3 3
Dizziness 2 2
Unspecified Respiratory Problem 2 2
Headache 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
Foreign Body In Patient 1 1
Vomiting 1 1
Unspecified Hepatic or Biliary Problem 1 1
Tachycardia 1 1
Unspecified Tissue Injury 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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