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TPLC
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show TPLC since
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Device
tube, tracheostomy (w/wo connector)
Product Code
BTO
Regulation Number
868.5800
Device Class
2
Premarket Reviews
Manufacturer
Decision
COOK, INC.
SUBSTANTIALLY EQUIVALENT
1
PRIMED HALBERSTADT MEDIZINTECHNIK GMBH
SUBSTANTIALLY EQUIVALENT
1
REGULATORY AND MARKETING SERVICES, INC.
SUBSTANTIALLY EQUIVALENT
1
1. K101721
WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER C
...
SMITHS MEDICAL ADS, INC.
SUBSTANTIALLY EQUIVALENT
1
SMITHS MEDICAL ASD, INC.
SUBSTANTIALLY EQUIVALENT
1
TELEFLEX MEDICAL
SUBSTANTIALLY EQUIVALENT
1
VENNER MEDICAL (SINGAPORE) PTE LTD
SUBSTANTIALLY EQUIVALENT
2
VITALTEC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
173
173
2015
171
171
2016
212
212
2017
125
125
2018
162
162
2019
87
87
2020
113
113
2021
198
198
2022
770
770
2023
402
402
2024
119
119
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
312
312
Gas/Air Leak
240
240
Air Leak
239
239
Inflation Problem
223
223
Break
169
169
Detachment of Device or Device Component
115
115
Crack
82
82
Fracture
77
77
Connection Problem
62
62
Defective Component
59
59
Disconnection
57
57
Material Separation
51
51
Component Missing
49
49
Contamination /Decontamination Problem
47
47
Fluid/Blood Leak
42
42
Material Split, Cut or Torn
42
42
Material Puncture/Hole
40
40
Deflation Problem
36
36
Device Markings/Labelling Problem
34
34
Decrease in Pressure
32
32
Separation Problem
31
31
Defective Device
29
29
Obstruction of Flow
27
27
Detachment Of Device Component
27
27
Material Deformation
26
26
Material Integrity Problem
25
25
Use of Device Problem
25
25
Unintended Deflation
25
25
Incomplete or Missing Packaging
23
23
Device Damaged Prior to Use
23
23
Inadequacy of Device Shape and/or Size
22
22
Accessory Incompatible
20
20
Human-Device Interface Problem
20
20
Loose or Intermittent Connection
19
19
Pressure Problem
18
18
Material Rupture
17
17
Suction Problem
17
17
Tear, Rip or Hole in Device Packaging
16
16
Insufficient Information
16
16
Mechanical Problem
15
15
Material Discolored
15
15
Difficult to Insert
14
14
Adverse Event Without Identified Device or Use Problem
13
13
Device Operates Differently Than Expected
12
12
Difficult to Remove
12
12
Material Fragmentation
11
11
Gel Leak
11
11
Device Dislodged or Dislocated
11
11
Material Twisted/Bent
11
11
Moisture or Humidity Problem
10
10
Nonstandard Device
10
10
Patient Device Interaction Problem
10
10
Manufacturing, Packaging or Shipping Problem
10
10
Torn Material
10
10
Hole In Material
8
8
Material Perforation
8
8
Fitting Problem
8
8
Deformation Due to Compressive Stress
7
7
Degraded
7
7
Device Alarm System
7
7
Unintended Movement
7
7
Positioning Problem
7
7
Material Too Soft/Flexible
7
7
Noise, Audible
7
7
Physical Resistance/Sticking
7
7
Complete Blockage
6
6
Component(s), broken
6
6
Sticking
6
6
No Pressure
6
6
Expiration Date Error
6
6
Split
6
6
Improper or Incorrect Procedure or Method
5
5
Problem with Sterilization
5
5
Packaging Problem
5
5
Compatibility Problem
5
5
Product Quality Problem
5
5
Labelling, Instructions for Use or Training Problem
5
5
Burst Container or Vessel
5
5
Bent
5
5
Partial Blockage
5
5
Premature Separation
5
5
Appropriate Term/Code Not Available
4
4
Component Incompatible
4
4
Occlusion Within Device
4
4
Unsealed Device Packaging
4
4
Infusion or Flow Problem
4
4
Optical Discoloration
4
4
Difficult to Advance
4
4
Contamination of Device Ingredient or Reagent
4
4
Insufficient Flow or Under Infusion
4
4
Failure to Disconnect
4
4
Separation Failure
4
4
Structural Problem
4
4
Malposition of Device
4
4
Patient-Device Incompatibility
4
4
Cut In Material
3
3
Tidal Volume Fluctuations
3
3
Device Contamination with Body Fluid
3
3
Failure to Deliver
3
3
Migration or Expulsion of Device
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1194
1194
No Consequences Or Impact To Patient
579
579
Insufficient Information
209
209
No Known Impact Or Consequence To Patient
144
144
Extubate
81
81
No Information
58
59
Low Oxygen Saturation
43
43
Therapy/non-surgical treatment, additional
31
31
Decreased Respiratory Rate
29
29
No Patient Involvement
27
27
Airway Obstruction
24
24
Dyspnea
16
16
Respiratory Distress
16
16
No Code Available
16
16
Hemorrhage/Bleeding
13
13
Hypoxia
12
12
Death
12
12
Foreign Body In Patient
10
10
Discomfort
9
9
Pneumothorax
8
8
Bradycardia
8
8
Unintended Extubation
8
8
Respiratory Insufficiency
7
7
Hypoventilation
7
7
Cardiac Arrest
6
6
Aspiration/Inhalation
6
6
Aspiration Pneumonitis
6
6
Device Embedded In Tissue or Plaque
6
6
Pain
5
5
Ventilator Dependent
5
5
Respiratory Failure
4
4
Pressure Sores
4
4
Patient Problem/Medical Problem
4
4
Blood Loss
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Distress
3
3
Tissue Damage
3
3
Irritation
3
3
Pneumonia
3
3
Injury
3
3
Abrasion
3
3
Cyanosis
3
3
Fistula
3
3
Unspecified Infection
3
3
Failure of Implant
2
2
Granuloma
2
2
Pulmonary Emphysema
2
2
Abnormal Blood Gases
2
2
Apnea
2
2
Laceration(s) of Esophagus
2
2
Fever
2
2
Laceration(s)
2
2
Ventricular Fibrillation
2
2
Ventricular Tachycardia
2
2
Swelling
2
2
Brain Injury
2
2
Swelling/ Edema
2
2
Blister
2
2
Ulcer
2
2
Diminished Pulse Pressure
1
1
Confusion/ Disorientation
1
1
Loss Of Pulse
1
1
Hospitalization required
1
1
Fluid Discharge
1
1
Myocardial Hypertrophy
1
1
Skin Inflammation/ Irritation
1
1
Respiratory Arrest
1
1
Hematemesis
1
1
Salivary Hypersecretion
1
1
Stomatitis
1
1
Urethral Stenosis/Stricture
1
1
Shock, Traumatic
1
1
Thrombosis
1
1
Perforation
1
1
Pulmonary Edema
1
1
Perforation of Esophagus
1
1
Sore Throat
1
1
Loss of consciousness
1
1
Obstruction/Occlusion
1
1
Forced Expiratory Volume Decreased
1
1
Skin Inflammation
1
1
Diaphoresis
1
1
Needle Stick/Puncture
1
1
Nasal Obstruction
1
1
Bacterial Infection
1
1
Wound Dehiscence
1
1
Adult Respiratory Distress Syndrome
1
1
Bruise/Contusion
1
1
Chemosis
1
1
Chest Pain
1
1
Crushing Injury
1
1
Encephalopathy
1
1
Fatigue
1
1
Intracranial Hemorrhage
1
1
Hypersensitivity/Allergic reaction
1
1
Hyperventilation
1
1
Low Blood Pressure/ Hypotension
1
1
Hypovolemic Shock
1
1
Infiltration into Tissue
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ambu Inc.
II
Mar-24-2016
2
Arcadia Medical Corporation
II
May-21-2012
3
Arcadia Medical Corporation
II
Jun-24-2011
4
Bryan Medical Inc
I
Jul-08-2013
5
Cardinal Health 200, LLC
I
Feb-16-2024
6
Gf Health Products, Inc.
II
Nov-09-2009
7
Instrumentation Industries Inc
II
Nov-12-2015
8
Instrumentation Industries Inc
II
Sep-03-2009
9
Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
I
May-06-2010
10
Smiths Medical ASD Inc.
II
Jun-04-2019
11
Smiths Medical ASD Inc.
II
Jun-07-2018
12
Smiths Medical ASD, Inc.
I
Jan-19-2012
13
VBM Medical Inc.
II
Jun-28-2011
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