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TPLC
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show TPLC since
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2024
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Device
connector, airway (extension)
Product Code
BZA
Regulation Number
868.5810
Device Class
1
Premarket Reviews
Manufacturer
Decision
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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