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TPLC
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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
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
265
265
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
318
318
Gas/Air Leak
270
270
Air Leak
239
239
Inflation Problem
235
235
Break
188
188
Detachment of Device or Device Component
118
118
Crack
100
100
Fracture
82
82
Connection Problem
64
64
Disconnection
62
62
Defective Component
61
61
Material Separation
53
53
Component Missing
49
49
Material Split, Cut or Torn
47
47
Fluid/Blood Leak
47
47
Contamination /Decontamination Problem
47
47
Material Puncture/Hole
44
44
Deflation Problem
40
40
Device Markings/Labelling Problem
36
36
Decrease in Pressure
35
35
Separation Problem
32
32
Defective Device
29
29
Unintended Deflation
28
28
Obstruction of Flow
27
27
Detachment Of Device Component
27
27
Material Deformation
26
26
Inadequacy of Device Shape and/or Size
26
26
Material Integrity Problem
26
26
Use of Device Problem
25
25
Device Damaged Prior to Use
23
23
Incomplete or Missing Packaging
23
23
Loose or Intermittent Connection
21
21
Accessory Incompatible
20
20
Human-Device Interface Problem
20
20
Material Rupture
19
19
Suction Problem
18
18
Fitting Problem
18
18
Pressure Problem
18
18
Insufficient Information
17
17
Tear, Rip or Hole in Device Packaging
16
16
Mechanical Problem
16
16
Material Discolored
15
15
Difficult to Insert
14
14
Adverse Event Without Identified Device or Use Problem
13
13
Device Dislodged or Dislocated
12
12
Device Operates Differently Than Expected
12
12
Difficult to Remove
12
12
Material Twisted/Bent
11
11
Gel Leak
11
11
Material Fragmentation
11
11
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1322
1322
No Consequences Or Impact To Patient
579
579
Insufficient Information
222
222
No Known Impact Or Consequence To Patient
144
144
Extubate
81
81
No Information
58
59
Low Oxygen Saturation
44
44
Therapy/non-surgical treatment, additional
31
31
Decreased Respiratory Rate
29
29
No Patient Involvement
27
27
Airway Obstruction
24
24
Dyspnea
16
16
No Code Available
16
16
Respiratory Distress
16
16
Hemorrhage/Bleeding
13
13
Death
12
12
Hypoxia
12
12
Foreign Body In Patient
10
10
Discomfort
9
9
Pneumothorax
8
8
Unintended Extubation
8
8
Aspiration/Inhalation
8
8
Bradycardia
8
8
Cardiac Arrest
7
7
Hypoventilation
7
7
Respiratory Insufficiency
7
7
Device Embedded In Tissue or Plaque
6
6
Aspiration Pneumonitis
6
6
Ventilator Dependent
5
5
Pain
5
5
Pressure Sores
4
4
Respiratory Failure
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Blood Loss
4
4
Patient Problem/Medical Problem
4
4
Tissue Damage
3
3
Pneumonia
3
3
Distress
3
3
Irritation
3
3
Fistula
3
3
Injury
3
3
Unspecified Infection
3
3
Cyanosis
3
3
Abrasion
3
3
Apnea
3
3
Blister
2
2
Ventricular Fibrillation
2
2
Fever
2
2
Laceration(s) of Esophagus
2
2
Swelling
2
2
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.
I
Sep-11-2024
11
Smiths Medical ASD Inc.
I
Aug-23-2024
12
Smiths Medical ASD Inc.
II
Jun-04-2019
13
Smiths Medical ASD Inc.
II
Jun-07-2018
14
Smiths Medical ASD, Inc.
I
Jan-19-2012
15
VBM Medical Inc.
II
Jun-28-2011
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