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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
2019 80 80
2020 30 30
2021 62 62
2022 51 51
2023 52 52
2024 55 55

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 55 55
Inflation Problem 34 34
Deflation Problem 24 24
Leak/Splash 18 18
Break 18 18
Material Separation 18 18
Adverse Event Without Identified Device or Use Problem 14 14
Detachment of Device or Device Component 10 10
Deformation Due to Compressive Stress 8 8
Physical Resistance/Sticking 8 8
Material Split, Cut or Torn 7 7
Inadequacy of Device Shape and/or Size 6 6
Material Integrity Problem 6 6
Obstruction of Flow 6 6
Disconnection 5 5
Appropriate Term/Code Not Available 5 5
Device Damaged Prior to Use 5 5
Material Protrusion/Extrusion 5 5
Material Puncture/Hole 5 5
Contamination /Decontamination Problem 5 5
Use of Device Problem 5 5
Fitting Problem 4 4
Material Deformation 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Structural Problem 4 4
Pressure Problem 3 3
Separation Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Loose or Intermittent Connection 3 3
Nonstandard Device 3 3
Device Dislodged or Dislocated 3 3
Insufficient Information 3 3
Device Handling Problem 3 3
Material Rupture 3 3
Difficult to Insert 3 3
Fracture 2 2
Delivered as Unsterile Product 2 2
Infusion or Flow Problem 2 2
Material Too Rigid or Stiff 2 2
Material Fragmentation 2 2
Patient Device Interaction Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Positioning Problem 2 2
Defective Device 2 2
Unintended Movement 2 2
Complete Blockage 2 2
Device Markings/Labelling Problem 2 2
Device Misassembled During Manufacturing /Shipping 1 1
Dent in Material 1 1
Shipping Damage or Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 162 162
No Consequences Or Impact To Patient 58 58
Insufficient Information 25 25
No Patient Involvement 24 24
No Known Impact Or Consequence To Patient 15 15
Foreign Body In Patient 6 6
Low Oxygen Saturation 5 5
Pain 4 4
Cardiac Arrest 3 3
Numbness 3 3
Hypoxia 3 3
Airway Obstruction 3 3
Unintended Extubation 3 3
Cyanosis 2 2
Death 2 2
Hypoventilation 2 2
No Code Available 2 2
Ecchymosis 2 2
Laceration(s) 2 2
Respiratory Insufficiency 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Respiratory Arrest 1 1
Unspecified Gastrointestinal Problem 1 1
Hematoma 1 1
Abrasion 1 1
Laceration(s) of Esophagus 1 1
Obstruction/Occlusion 1 1
Dysphagia/ Odynophagia 1 1
Pulmonary Edema 1 1
Bronchospasm 1 1
Unspecified Tissue Injury 1 1
Ulcer 1 1
Hemorrhage/Bleeding 1 1
Pressure Sores 1 1
Extubate 1 1
Respiratory Failure 1 1
Bruise/Contusion 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bound Tree Medical II Jul-10-2020
2 Intersurgical Inc II Oct-17-2022
3 King Systems Corp. dba Ambu, Inc. II Oct-30-2024
4 King Systems Corp. dba Ambu, Inc. II May-29-2019
5 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
6 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Jul-21-2023
8 MEDLINE INDUSTRIES, LP - Northfield II Apr-14-2022
9 Sarnova HC, Llc II Jan-12-2024
10 SunMed Holdings, LLC II Jan-26-2023
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