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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 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 29 29
Gas/Air Leak 16 16
Break 14 14
Crack 14 14
Connection Problem 13 13
Material Separation 12 12
Leak/Splash 8 8
Disconnection 7 7
Loose or Intermittent Connection 5 5
Defective Device 4 4
Use of Device Problem 4 4
Detachment of Device or Device Component 4 4
Fracture 4 4
Mechanical Problem 3 3
Material Fragmentation 3 3
Component Incompatible 3 3
Failure to Disconnect 3 3
Fitting Problem 2 2
Incomplete or Inadequate Connection 2 2
Defective Component 2 2
Degraded 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
Failure to Transmit Record 1 1
Material Integrity Problem 1 1
Moisture Damage 1 1
Component Missing 1 1
Material Twisted/Bent 1 1
Blocked Connection 1 1
Packaging Problem 1 1
Device Handling Problem 1 1
Improper Chemical Reaction 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 77 77
No Consequences Or Impact To Patient 13 13
No Known Impact Or Consequence To Patient 11 11
Insufficient Information 7 7
Hypoventilation 4 4
Low Oxygen Saturation 4 4
Hypoxia 3 3
Foreign Body In Patient 2 2
Unspecified Respiratory Problem 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
Dizziness 1 1
Aspiration/Inhalation 1 1
Asthma 1 1
Vomiting 1 1
No Patient Involvement 1 1
Tachycardia 1 1
Unspecified Tissue Injury 1 1
Hyperventilation 1 1
Headache 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 May-12-2023
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