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TPLC
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show TPLC since
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2024
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Device
tube, tracheostomy (w/wo connector)
Product Code
BTO
Regulation Number
868.5800
Device Class
2
Premarket Reviews
Manufacturer
Decision
TELEFLEX MEDICAL
SUBSTANTIALLY EQUIVALENT
1
VENNER MEDICAL (SINGAPORE) PTE LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
87
87
2020
113
113
2021
198
198
2022
770
770
2023
402
402
2024
361
361
Device Problems
MDRs with this Device Problem
Events in those MDRs
Gas/Air Leak
293
293
Leak/Splash
186
186
Inflation Problem
184
184
Break
141
141
Detachment of Device or Device Component
114
114
Disconnection
81
81
Crack
74
74
Connection Problem
61
61
Defective Component
57
57
Material Split, Cut or Torn
50
50
Material Separation
48
48
Contamination /Decontamination Problem
47
47
Material Puncture/Hole
45
45
Component Missing
43
43
Fluid/Blood Leak
42
42
Device Markings/Labelling Problem
38
38
Fracture
35
35
Unintended Deflation
35
35
Separation Problem
32
32
Defective Device
28
28
Obstruction of Flow
24
24
Use of Device Problem
23
23
Incomplete or Missing Packaging
22
22
Deflation Problem
21
21
Material Deformation
20
20
Accessory Incompatible
19
19
Loose or Intermittent Connection
18
18
Insufficient Information
17
17
Decrease in Pressure
17
17
Inadequacy of Device Shape and/or Size
16
16
Device Damaged Prior to Use
16
16
Tear, Rip or Hole in Device Packaging
15
15
Material Discolored
15
15
Mechanical Problem
14
14
Fitting Problem
12
12
Pressure Problem
12
12
Difficult to Insert
12
12
Suction Problem
11
11
Material Integrity Problem
11
11
Gel Leak
11
11
Material Twisted/Bent
10
10
Moisture or Humidity Problem
10
10
Material Rupture
10
10
Patient Device Interaction Problem
10
10
Device Dislodged or Dislocated
9
9
Nonstandard Device
9
9
Material Fragmentation
9
9
Difficult to Remove
8
8
Physical Resistance/Sticking
8
8
Material Too Soft/Flexible
7
7
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1414
1414
Insufficient Information
223
223
No Consequences Or Impact To Patient
115
115
Decreased Respiratory Rate
29
29
Low Oxygen Saturation
29
29
Extubate
20
20
No Information
19
19
Airway Obstruction
19
19
No Known Impact Or Consequence To Patient
13
13
Dyspnea
9
9
Unintended Extubation
8
8
No Patient Involvement
8
8
Respiratory Insufficiency
7
7
Aspiration Pneumonitis
6
6
Hemorrhage/Bleeding
6
6
Cardiac Arrest
5
5
Bradycardia
5
5
Hypoventilation
5
5
Hypoxia
5
5
No Code Available
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Aspiration/Inhalation
4
4
Abrasion
3
3
Fever
3
3
Fistula
3
3
Foreign Body In Patient
3
3
Patient Problem/Medical Problem
3
3
Death
3
3
Laceration(s) of Esophagus
2
2
Ventilator Dependent
2
2
Respiratory Failure
2
2
Swelling/ Edema
2
2
Blister
2
2
Skin Inflammation/ Irritation
2
2
Device Embedded In Tissue or Plaque
2
2
Failure of Implant
2
2
Brain Injury
2
2
Pneumonia
2
2
Pneumothorax
2
2
Chest Pain
2
2
Chemosis
1
1
Intracranial Hemorrhage
1
1
Hypersensitivity/Allergic reaction
1
1
Low Blood Pressure/ Hypotension
1
1
Adult Respiratory Distress Syndrome
1
1
Wound Dehiscence
1
1
Stacking Breaths
1
1
Bruise/Contusion
1
1
Apnea
1
1
Respiratory Distress
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardinal Health 200, LLC
I
Feb-16-2024
2
Smiths Medical ASD Inc.
I
Sep-11-2024
3
Smiths Medical ASD Inc.
I
Aug-23-2024
4
Smiths Medical ASD Inc.
II
Jun-04-2019
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