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

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
Break 14 14
Connection Problem 13 13
Material Separation 11 11
Disconnection 8 8
Leak/Splash 5 5
Defective Device 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
Degraded 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
Component Incompatible 1 1
Improper Chemical Reaction 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
Hypoxia 3 3
Low Oxygen Saturation 3 3
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
Asthma 1 1
Foreign Body In Patient 1 1
Vomiting 1 1
Tachycardia 1 1
Unspecified Tissue Injury 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 Oct-23-2024
4 Smiths Medical ASD Inc. II May-12-2023
5 Westmed, Inc. II Oct-30-2024
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