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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)
Product CodeBZA
Regulation Number 868.5810
Device Class 1

MDR Year MDR Reports MDR Events
2019 13 13
2020 21 21
2021 15 15
2022 21 21
2023 39 39
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 28 28
Gas/Air Leak 16 16
Crack 14 14
Break 13 13
Material Separation 12 12
Connection Problem 12 12
Leak/Splash 8 8
Disconnection 7 7
Loose or Intermittent Connection 5 5
Fracture 4 4
Material Fragmentation 3 3
Component Incompatible 3 3
Mechanical Problem 3 3
Use of Device Problem 3 3
Detachment of Device or Device Component 3 3
Failure to Disconnect 3 3
Defective Device 3 3
Incomplete or Inadequate Connection 2 2
Fitting Problem 2 2
Misconnection 2 2
Moisture Damage 1 1
Material Puncture/Hole 1 1
Failure to Transmit Record 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Component Missing 1 1
Degraded 1 1
Material Disintegration 1 1
Fluid/Blood Leak 1 1
Blocked Connection 1 1
Separation Failure 1 1
Improper Chemical Reaction 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Twisted/Bent 1 1
Output Problem 1 1
Packaging Problem 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 76 76
No Consequences Or Impact To Patient 13 13
No Known Impact Or Consequence To Patient 11 11
Insufficient Information 6 6
Low Oxygen Saturation 3 3
Hypoventilation 3 3
Foreign Body In Patient 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hypoxia 1 1
Tachycardia 1 1
Aspiration/Inhalation 1 1
Hyperventilation 1 1
Low Blood Pressure/ Hypotension 1 1
No Patient Involvement 1 1
Unspecified Tissue Injury 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 May-12-2023
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