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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


Premarket Reviews
ManufacturerDecision
MERGENET MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 17 17
2015 20 20
2016 5 5
2017 19 19
2018 15 15
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
Crack 24 24
Break 23 23
Gas/Air Leak 17 17
Disconnection 15 15
Connection Problem 15 15
Melted 15 15
Material Separation 14 14
Leak/Splash 11 11
Air Leak 8 8
Fitting Problem 7 7
Loose or Intermittent Connection 7 7
Device Contamination with Chemical or Other Material 6 6
Detachment Of Device Component 5 5
Defective Device 5 5
Detachment of Device or Device Component 5 5
Material Fragmentation 4 4
Fracture 4 4
Hole In Material 4 4
Use of Device Problem 4 4
Failure to Disconnect 3 3
Component Incompatible 3 3
Mechanical Problem 3 3
Degraded 2 2
Misconnection 2 2
Device Handling Problem 2 2
Material Rupture 2 2
Packaging Problem 2 2
Material Integrity Problem 2 2
Defective Component 2 2
Incomplete or Inadequate Connection 2 2
Intermittent Loss of Power 1 1
Device Issue 1 1
Improper Chemical Reaction 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Blocked Connection 1 1
Out-Of-Box Failure 1 1
Mechanics Altered 1 1
Material Twisted/Bent 1 1
Obstruction of Flow 1 1
Component Missing 1 1
Occlusion Within Device 1 1
Moisture Damage 1 1
Output Problem 1 1
Incorrect Measurement 1 1
Failure to Transmit Record 1 1
Temperature Problem 1 1
Fluid/Blood Leak 1 1
Inaccurate Delivery 1 1
Stretched 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 57 57
No Known Impact Or Consequence To Patient 34 34
No Patient Involvement 11 11
Insufficient Information 7 7
Low Oxygen Saturation 7 7
Hypoventilation 5 5
Hypoxia 4 4
Death 2 2
Foreign Body In Patient 2 2
Dyspnea 2 2
Unspecified Respiratory Problem 2 2
Extubate 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
No Information 1 1
Dizziness 1 1
Aspiration/Inhalation 1 1
Asthma 1 1
Weakness 1 1
Vomiting 1 1
Anxiety 1 1
Tachycardia 1 1
Unspecified Tissue Injury 1 1
Hyperventilation 1 1
Headache 1 1
Cancer 1 1
Unintended Extubation 1 1
Ambulation Difficulties 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bioseal Corporation II Aug-13-2020
2 Intersurgical Inc II Jan-08-2020
3 King Systems Corp. II Apr-01-2015
4 Smiths Medical ASD Inc. II May-12-2023
5 Telefelx Medical II Jan-15-2010
6 Teleflex Medical II Sep-16-2009
7 Teleflex Medical Europe Ltd II Apr-17-2018
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