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TPLC
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Device
tube, tracheal (w/wo connector)
Product Code
BTR
Regulation Number
868.5730
Device Class
2
Premarket Reviews
Manufacturer
Decision
BRYAN MEDICAL , INC.
SUBSTANTIALLY EQUIVALENT
1
BRYAN MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN
SUBSTANTIALLY EQUIVALENT
1
JIANGXI YIKANG MEDICAL INSTRUMENT GROUP CO., LTD
SUBSTANTIALLY EQUIVALENT
1
SALTER LABS, INC.
SUBSTANTIALLY EQUIVALENT
1
SECURISYN MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
TELEFLEXMEDICAL, INC
SUBSTANTIALLY EQUIVALENT
1
TIANJIN MEDIS MEDICAL DEVICE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
VENNER MEDICAL (SINGAPORE) PTE LTD
SUBSTANTIALLY EQUIVALENT
1
WELL LEAD MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2019
1379
1379
2020
1070
1070
2021
1329
1329
2022
1132
1132
2023
1331
1331
2024
371
371
Device Problems
MDRs with this Device Problem
Events in those MDRs
Gas/Air Leak
1834
1834
Use of Device Problem
1376
1376
Inflation Problem
498
498
Defective Component
386
386
Material Split, Cut or Torn
365
365
Leak/Splash
354
354
Disconnection
232
232
Detachment of Device or Device Component
182
182
Connection Problem
173
173
Deflation Problem
129
129
Material Puncture/Hole
106
106
Material Integrity Problem
87
87
Break
82
82
Obstruction of Flow
78
78
Insufficient Information
73
73
Material Separation
73
73
Contamination /Decontamination Problem
70
70
Material Deformation
68
68
Appropriate Term/Code Not Available
65
65
Loose or Intermittent Connection
63
63
Device Markings/Labelling Problem
61
61
Material Rupture
57
57
Deformation Due to Compressive Stress
55
55
Material Twisted/Bent
54
54
Pressure Problem
53
53
Unintended Deflation
52
52
Fluid/Blood Leak
51
51
Crack
50
50
Labelling, Instructions for Use or Training Problem
47
47
Separation Problem
46
46
Mechanical Problem
33
33
Human-Device Interface Problem
33
33
Defective Device
27
27
Patient-Device Incompatibility
27
27
Component Missing
21
21
Adverse Event Without Identified Device or Use Problem
20
20
Decrease in Pressure
20
20
Fracture
19
19
Physical Resistance/Sticking
18
18
Component Incompatible
16
16
Burst Container or Vessel
16
16
Delivered as Unsterile Product
16
16
Inadequacy of Device Shape and/or Size
16
16
Material Too Rigid or Stiff
15
15
Partial Blockage
15
15
Material Fragmentation
15
15
Malposition of Device
15
15
Tear, Rip or Hole in Device Packaging
14
14
Fitting Problem
14
14
Difficult to Remove
12
12
Gel Leak
12
12
Device Dislodged or Dislocated
12
12
Manufacturing, Packaging or Shipping Problem
11
11
Device Damaged Prior to Use
11
11
Unsealed Device Packaging
11
11
Peeled/Delaminated
11
11
Complete Blockage
10
10
Failure to Deflate
10
10
Difficult to Insert
9
9
Suction Problem
9
9
Patient Device Interaction Problem
9
9
Therapeutic or Diagnostic Output Failure
9
9
Structural Problem
8
8
Device Misassembled During Manufacturing /Shipping
8
8
Nonstandard Device
8
8
Off-Label Use
8
8
Product Quality Problem
7
7
Migration or Expulsion of Device
7
7
Tidal Volume Fluctuations
7
7
Improper Flow or Infusion
7
7
Separation Failure
6
6
Output Problem
6
6
Improper or Incorrect Procedure or Method
6
6
Device Contaminated During Manufacture or Shipping
5
5
Infusion or Flow Problem
5
5
Material Too Soft/Flexible
5
5
Illegible Information
4
4
Missing Information
4
4
Mechanical Jam
4
4
Ventilation Problem in Device Environment
4
4
Failure to Disconnect
4
4
Blocked Connection
4
4
Increase in Pressure
4
4
Entrapment of Device
4
4
Loss of or Failure to Bond
4
4
Device Alarm System
4
4
False Alarm
4
4
Contamination
4
4
Degraded
3
3
Material Discolored
3
3
Collapse
3
3
Unintended Ejection
3
3
Material Invagination
3
3
Insufficient Flow or Under Infusion
3
3
Material Perforation
3
3
Device Slipped
3
3
Contamination of Device Ingredient or Reagent
3
3
Dent in Material
3
3
Failure to Deliver
3
3
No Apparent Adverse Event
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2403
2403
Unintended Extubation
1114
1114
Extubate
692
692
No Consequences Or Impact To Patient
648
648
Insufficient Information
643
643
No Patient Involvement
504
504
No Known Impact Or Consequence To Patient
283
283
Low Oxygen Saturation
220
220
No Information
176
176
Unspecified Tissue Injury
60
60
Hypoventilation
59
59
Hypoxia
55
55
Airway Obstruction
39
39
Cardiac Arrest
30
30
Decreased Respiratory Rate
30
30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
29
29
Death
28
28
Respiratory Insufficiency
27
27
Hemorrhage/Bleeding
25
25
Injury
20
20
Pneumothorax
19
19
Unspecified Respiratory Problem
16
16
Respiratory Arrest
15
15
Respiratory Failure
15
15
No Code Available
14
14
Dyspnea
14
14
Bradycardia
14
14
Swelling/ Edema
13
13
Bronchospasm
12
12
Foreign Body In Patient
10
10
Aspiration/Inhalation
10
10
Respiratory Distress
10
10
Obstruction/Occlusion
9
9
Pain
8
8
Tissue Damage
7
7
Increased Respiratory Rate
7
7
Pneumonia
6
6
Swelling
6
6
Pulmonary Emphysema
6
6
Granuloma
6
6
Low Blood Pressure/ Hypotension
5
5
Tachycardia
5
5
Patient Problem/Medical Problem
5
5
Device Embedded In Tissue or Plaque
5
5
Wheezing
4
4
Ventilator Dependent
4
4
Reaction
4
4
Discomfort
4
4
Adult Respiratory Distress Syndrome
4
4
Apnea
3
3
Bronchitis
3
3
Laceration(s)
3
3
Ulcer
3
3
Forced Expiratory Volume Increased
3
3
Post Traumatic Wound Infection
3
3
Respiratory Acidosis
2
2
Anxiety
2
2
Distress
2
2
Complaint, Ill-Defined
2
2
Pulmonary Edema
2
2
Vomiting
2
2
Anaphylactoid
2
2
Necrosis
2
2
High Blood Pressure/ Hypertension
2
2
Unspecified Infection
2
2
Erythema
2
2
Edema
2
2
Dysphagia/ Odynophagia
2
2
Stacking Breaths
2
2
Abrasion
2
2
Asystole
2
2
Localized Skin Lesion
2
2
Skin Inflammation/ Irritation
2
2
Unintended Radiation Exposure
2
2
Fluid Discharge
2
2
Blood Loss
1
1
Test Result
1
1
Convulsion/Seizure
1
1
Aphonia
1
1
Ischemia Stroke
1
1
Multiple Fractures
1
1
Abscess
1
1
Abnormal Blood Gases
1
1
Arrhythmia
1
1
Asthma
1
1
Cardiopulmonary Arrest
1
1
Cellulitis
1
1
Chest Pain
1
1
Cyanosis
1
1
Cardiac Enzyme Elevation
1
1
Intracranial Hemorrhage
1
1
Hypersensitivity/Allergic reaction
1
1
Inflammation
1
1
Occlusion
1
1
Burning Sensation
1
1
Therapeutic Effects, Unexpected
1
1
Paresis
1
1
Perforation
1
1
Pleural Effusion
1
1
Respiratory Distress Syndrome of Newborns
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Centurion Medical Products Corporation
I
Jul-30-2019
2
Covidien
II
Apr-01-2023
3
Flexicare Medical Ltd.
I
Nov-26-2020
4
Smiths Medical ASD Inc.
II
Oct-27-2021
5
TELEFLEX LLC
I
Jun-29-2023
6
TELEFLEX LLC
II
Jan-23-2023
7
TELEFLEX MEDICAL INC
II
Jul-10-2020
8
Teleflex Medical
I
Sep-09-2019
9
Teleflex Medical
I
Jun-19-2019
10
Teleflex Medical
II
May-29-2019
11
Teleflex Medical Europe Ltd
II
Aug-19-2021
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