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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 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 28 28
Crack 24 24
Break 22 22
Gas/Air Leak 17 17
Disconnection 15 15
Melted 15 15
Material Separation 14 14
Connection Problem 14 14
Leak/Splash 11 11
Air Leak 8 8
Loose or Intermittent Connection 7 7
Fitting Problem 7 7
Device Contamination with Chemical or Other Material 6 6
Detachment Of Device Component 5 5
Fracture 4 4
Material Fragmentation 4 4
Hole In Material 4 4
Defective Device 4 4
Detachment of Device or Device Component 4 4
Failure to Disconnect 3 3
Use of Device Problem 3 3
Component Incompatible 3 3
Mechanical Problem 3 3
Misconnection 2 2
Material Rupture 2 2
Packaging Problem 2 2
Device Handling Problem 2 2
Incomplete or Inadequate Connection 2 2
Intermittent Loss of Power 1 1
Temperature Problem 1 1
Torn Material 1 1
Improper Chemical Reaction 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Mechanics Altered 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output Problem 1 1
Stretched 1 1
Separation Failure 1 1
Blocked Connection 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Component Missing 1 1
Out-Of-Box Failure 1 1
Inaccurate Delivery 1 1
Device Issue 1 1
Obstruction of Flow 1 1
Moisture Damage 1 1
Occlusion Within Device 1 1
Material Puncture/Hole 1 1
Failure to Transmit Record 1 1
Incorrect Measurement 1 1
Degraded 1 1
Material Disintegration 1 1
Fluid/Blood Leak 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 57 57
No Known Impact Or Consequence To Patient 34 34
No Patient Involvement 11 11
Low Oxygen Saturation 6 6
Insufficient Information 6 6
Hypoventilation 4 4
Hypoxia 2 2
Death 2 2
Dyspnea 2 2
Foreign Body In Patient 2 2
Extubate 2 2
Aspiration/Inhalation 1 1
Anxiety 1 1
Ambulation Difficulties 1 1
Hyperventilation 1 1
Low Blood Pressure/ Hypotension 1 1
Tachycardia 1 1
Weakness 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Information 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 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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