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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device airway, oropharyngeal, anesthesiology
Product CodeCAE
Regulation Number 868.5110
Device Class 1

MDR Year MDR Reports MDR Events
2018 56 56
2019 80 80
2020 30 30
2021 62 62
2022 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 47 47
Deflation Problem 40 40
Inflation Problem 32 32
Break 16 16
Detachment of Device or Device Component 13 13
Deformation Due to Compressive Stress 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Physical Resistance/Sticking 7 7
Leak/Splash 6 6
Inadequacy of Device Shape and/or Size 5 5
Material Deformation 5 5
Material Protrusion/Extrusion 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Disconnection 5 5
Device Damaged Prior to Use 5 5
Material Rupture 4 4
Obstruction of Flow 4 4
Structural Problem 4 4
Material Separation 4 4
Material Integrity Problem 3 3
Sticking 3 3
Improper or Incorrect Procedure or Method 3 3
Fitting Problem 3 3
Material Puncture/Hole 3 3
Material Split, Cut or Torn 3 3
Separation Problem 3 3
Difficult to Insert 3 3
Loose or Intermittent Connection 2 2
Malposition of Device 2 2
Device Markings/Labelling Problem 2 2
Positioning Problem 2 2
Defective Device 2 2
Insufficient Information 2 2
Device Dislodged or Dislocated 2 2
Crack 2 2
Mechanical Problem 2 2
Nonstandard Device 2 2
Device Contamination with Chemical or Other Material 2 2
Unintended Movement 2 2
Infusion or Flow Problem 2 2
Complete Blockage 2 2
Fracture 2 2
Material Fragmentation 1 1
Material Too Rigid or Stiff 1 1
Air Leak 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Protective Measures Problem 1 1
Contamination 1 1
Pressure Problem 1 1
Defective Component 1 1
Dent in Material 1 1
Device-Device Incompatibility 1 1
Unintended Collision 1 1
Peeled/Delaminated 1 1
Product Quality Problem 1 1
Difficult To Position 1 1
Melted 1 1
Incorrect Measurement 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Use of Device Problem 1 1
Material Perforation 1 1
Split 1 1
Unintended Deflation 1 1
Difficult to Advance 1 1
Contamination /Decontamination Problem 1 1
Difficult or Delayed Positioning 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 94 94
No Consequences Or Impact To Patient 82 82
No Patient Involvement 30 30
No Known Impact Or Consequence To Patient 27 27
Insufficient Information 8 8
Extubate 8 8
Foreign Body In Patient 5 5
No Code Available 4 4
Low Oxygen Saturation 3 3
Numbness 3 3
Airway Obstruction 3 3
Unintended Extubation 2 2
Death 2 2
Ecchymosis 2 2
Hypoxia 2 2
Pulmonary Edema 1 1
Obstruction/Occlusion 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hematoma 1 1
Hypoventilation 1 1
Unspecified Gastrointestinal Problem 1 1
Dysphagia/ Odynophagia 1 1
Ulcer 1 1
Cardiac Arrest 1 1
Laceration(s) 1 1
Pain 1 1
Discomfort 1 1
Injury 1 1
Laceration(s) of Esophagus 1 1
Bronchospasm 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Besmed Health Business Corporation II Oct-15-2018
2 Bound Tree Medical II Jul-10-2020
3 Intersurgical Inc II Oct-17-2022
4 King Systems Corp. dba Ambu, Inc. II May-29-2019
5 MEDLINE INDUSTRIES, LP - Northfield II Apr-14-2022
6 SunMed Holdings, LLC II Jan-26-2023
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