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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
A.R GUIDE IN MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
BRYAN MEDICAL , INC.
SUBSTANTIALLY EQUIVALENT
1
BRYAN MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
ETVIEW LTD.
SUBSTANTIALLY EQUIVALENT
1
JIANGXI YIKANG MEDICAL INSTRUMENT GROUP CO., LTD
SUBSTANTIALLY EQUIVALENT
1
NEVAP, INC.
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
2
VENNER MEDICAL (SINGAPORE) PTE LTD
SUBSTANTIALLY EQUIVALENT
1
WELL LEAD MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
WILLIAM COOK EUROPE APS
SUBSTANTIALLY EQUIVALENT
1
ZHANJIANG STAR ENTERPRISE CO., LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
812
812
2018
973
973
2019
1379
1379
2020
1071
1071
2021
1326
1326
2022
595
595
Device Problems
MDRs with this Device Problem
Events in those MDRs
Gas Leak
1262
1262
Inflation Problem
956
956
Use of Device Problem
897
897
Leak/Splash
460
460
Defective Component
314
314
Disconnection
284
284
Material Split, Cut or Torn
198
198
Detachment of Device or Device Component
197
197
Connection Problem
144
144
Air Leak
139
139
Deflation Problem
131
131
Break
96
96
Material Separation
87
87
Material Puncture/Hole
76
76
Loose or Intermittent Connection
74
74
Material Deformation
74
74
Material Integrity Problem
69
69
Obstruction of Flow
66
66
Material Rupture
63
63
Device Markings/Labelling Problem
61
61
Insufficient Information
61
61
Pressure Problem
58
58
Appropriate Term/Code Not Available
55
55
Crack
52
52
Contamination /Decontamination Problem
50
50
Deformation Due to Compressive Stress
43
43
Human-Device Interface Problem
43
43
Material Twisted/Bent
40
40
Device Operates Differently Than Expected
39
39
Fluid Leak
38
38
Partial Blockage
33
33
Contamination
32
32
Mechanical Problem
26
26
Detachment Of Device Component
25
25
Defective Device
25
25
Contamination of Device Ingredient or Reagent
25
25
Component Missing
24
24
Inadequacy of Device Shape and/or Size
24
24
Labelling, Instructions for Use or Training Problem
23
23
Decrease in Pressure
23
23
Burst Container or Vessel
23
23
Inadequate Instructions for Healthcare Professional
22
22
Adverse Event Without Identified Device or Use Problem
22
22
Kinked
20
20
Fracture
17
17
Malposition of Device
16
16
Hole In Material
15
15
Device Damaged Prior to Use
14
14
Manufacturing, Packaging or Shipping Problem
13
13
Material Too Rigid or Stiff
13
13
Material Fragmentation
13
13
Material Discolored
12
12
Device Dislodged or Dislocated
12
12
Packaging Problem
12
12
Patient-Device Incompatibility
11
11
Peeled/Delaminated
11
11
Occlusion Within Device
10
10
Suction Problem
10
10
Gel Leak
10
10
Device Alarm System
10
10
Unintended Deflation
10
10
Tear, Rip or Hole in Device Packaging
9
9
Device Contamination with Chemical or Other Material
8
8
Complete Blockage
8
8
Product Quality Problem
8
8
Ejection Problem
8
8
Physical Resistance/Sticking
8
8
Patient Device Interaction Problem
7
7
Migration or Expulsion of Device
7
7
Bent
7
7
Output Problem
7
7
Therapeutic or Diagnostic Output Failure
6
6
Torn Material
6
6
Fitting Problem
6
6
Material Perforation
6
6
Separation Failure
6
6
Component Incompatible
6
6
Collapse
6
6
Difficult to Insert
6
6
Difficult to Remove
6
6
Tidal Volume Fluctuations
6
6
Separation Problem
6
6
Off-Label Use
5
5
Unintended Movement
5
5
No Flow
5
5
Device Contaminated During Manufacture or Shipping
5
5
Improper Flow or Infusion
4
4
Split
4
4
Device Emits Odor
4
4
Unsealed Device Packaging
4
4
False Alarm
4
4
Material Too Soft/Flexible
4
4
Failure to Deflate
4
4
Illegible Information
3
3
Loss of or Failure to Bond
3
3
Unintended Ejection
3
3
Increase in Pressure
3
3
Nonstandard Device
3
3
Delivered as Unsterile Product
3
3
Dent in Material
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1124
1124
No Consequences Or Impact To Patient
1083
1083
Extubate
1056
1056
No Patient Involvement
895
895
No Known Impact Or Consequence To Patient
738
738
Unintended Extubation
611
611
No Information
298
298
Insufficient Information
282
282
Low Oxygen Saturation
168
168
Hypoxia
53
53
Death
47
47
No Code Available
37
37
Unspecified Tissue Injury
32
32
Airway Obstruction
26
26
Injury
24
24
Cardiac Arrest
20
20
Pneumothorax
19
19
Respiratory Distress
19
19
Bradycardia
13
13
Respiratory Failure
13
13
Hypoventilation
12
12
Patient Problem/Medical Problem
12
12
Bronchospasm
12
12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
11
11
Hemorrhage/Bleeding
11
11
Aspiration/Inhalation
10
10
Dyspnea
9
9
Obstruction/Occlusion
9
9
Tissue Damage
8
8
Swelling
7
7
Unspecified Respiratory Problem
7
7
Respiratory Insufficiency
7
7
Device Embedded In Tissue or Plaque
6
6
Blood Loss
6
6
Pulmonary Emphysema
6
6
Granuloma
6
6
Low Blood Pressure/ Hypotension
5
5
Vomiting
5
5
Ventilator Dependent
5
5
Foreign Body In Patient
5
5
Respiratory Arrest
5
5
Swelling/ Edema
5
5
Reaction
4
4
Decreased Respiratory Rate
4
4
Tachycardia
4
4
Adult Respiratory Distress Syndrome
4
4
Pain
3
3
Laceration(s)
3
3
Edema
3
3
Bronchitis
3
3
Sedation
3
3
Increased Respiratory Rate
3
3
Forced Expiratory Volume Increased
3
3
Post Traumatic Wound Infection
3
3
Fluid Discharge
3
3
Unintended Radiation Exposure
2
2
Localized Skin Lesion
2
2
Respiratory Acidosis
2
2
Pneumonia
2
2
Complaint, Ill-Defined
2
2
Anaphylactoid
2
2
Skin Erosion
2
2
Skin Irritation
2
2
Atrial Fibrillation
2
2
Apnea
2
2
Cardiopulmonary Arrest
2
2
Necrosis
2
2
Unspecified Infection
2
2
Encephalopathy
2
2
Bone Fracture(s)
1
1
Intracranial Hemorrhage
1
1
Hypersensitivity/Allergic reaction
1
1
Inflammation
1
1
Occlusion
1
1
Paralysis
1
1
Perforation
1
1
Respiratory Distress Syndrome of Newborns
1
1
Cellulitis
1
1
Chest Pain
1
1
Cyanosis
1
1
Dysphagia/ Odynophagia
1
1
Abnormal Blood Gases
1
1
Stacking Breaths
1
1
Abscess
1
1
Suffocation
1
1
Therapeutic Effects, Unexpected
1
1
Burning Sensation
1
1
Rupture
1
1
Brain Injury
1
1
Ulcer
1
1
Anxiety
1
1
Distress
1
1
Discomfort
1
1
Choking
1
1
Loss Of Pulse
1
1
Coma
1
1
Loss of consciousness
1
1
Sore Throat
1
1
Sensitivity of Teeth
1
1
Tooth Fracture
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Centurion Medical Products Corporation
I
Jul-30-2019
2
Flexicare Medical Ltd.
I
Nov-26-2020
3
Smiths Medical ASD Inc.
II
Oct-27-2021
4
TELEFLEX MEDICAL INC
II
Jul-10-2020
5
Teleflex Medical
I
Sep-09-2019
6
Teleflex Medical
I
Jun-19-2019
7
Teleflex Medical
II
May-29-2019
8
Teleflex Medical
II
Feb-09-2017
9
Teleflex Medical Europe Ltd
II
Aug-19-2021
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