TPLC - Total Product Life Cycle

• Device: airway, oropharyngeal, anesthesiology
• Product Code: CAE
• 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	17	17

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	52	52
Inflation Problem	28	28
Deflation Problem	23	23
Break	18	18
Material Separation	17	17
Leak/Splash	10	10
Detachment of Device or Device Component	10	10
Adverse Event Without Identified Device or Use Problem	9	9
Deformation Due to Compressive Stress	8	8
Material Integrity Problem	6	6
Physical Resistance/Sticking	6	6
Inadequacy of Device Shape and/or Size	6	6
Obstruction of Flow	6	6
Device Damaged Prior to Use	5	5
Disconnection	5	5
Material Protrusion/Extrusion	5	5
Contamination /Decontamination Problem	5	5
Manufacturing, Packaging or Shipping Problem	4	4
Material Deformation	4	4
Material Split, Cut or Torn	4	4
Fitting Problem	4	4
Structural Problem	4	4
Use of Device Problem	4	4
Material Puncture/Hole	4	4
Difficult to Insert	3	3
Improper or Incorrect Procedure or Method	3	3
Material Rupture	3	3
Loose or Intermittent Connection	3	3
Nonstandard Device	3	3
Separation Problem	3	3
Device Handling Problem	3	3
Patient Device Interaction Problem	2	2
Unintended Movement	2	2
Insufficient Information	2	2
Appropriate Term/Code Not Available	2	2
Device Dislodged or Dislocated	2	2
Positioning Problem	2	2
Infusion or Flow Problem	2	2
Device Markings/Labelling Problem	2	2
Delivered as Unsterile Product	2	2
Fracture	2	2
Material Fragmentation	2	2
Complete Blockage	2	2
Defective Device	2	2
Malposition of Device	1	1
Dent in Material	1	1
Defective Component	1	1
Shipping Damage or Problem	1	1
Product Quality Problem	1	1
Material Too Rigid or Stiff	1	1
Contamination	1	1
Crack	1	1
Difficult or Delayed Positioning	1	1
Unintended Collision	1	1
Peeled/Delaminated	1	1
Incorrect Measurement	1	1
Mechanical Problem	1	1
Melted	1	1
Migration or Expulsion of Device	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Difficult to Advance	1	1
Pressure Problem	1	1
Protective Measures Problem	1	1
Output Problem	1	1
Material Twisted/Bent	1	1
Inaccurate Information	1	1
Unintended Deflation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	138	138
No Consequences Or Impact To Patient	58	58
No Patient Involvement	24	24
Insufficient Information	17	17
No Known Impact Or Consequence To Patient	15	15
Foreign Body In Patient	6	6
Low Oxygen Saturation	5	5
Hypoxia	3	3
Numbness	3	3
Airway Obstruction	3	3
Ecchymosis	2	2
Cardiac Arrest	2	2
Cyanosis	2	2
Death	2	2
Laceration(s)	2	2
No Code Available	2	2
Respiratory Insufficiency	2	2
Unintended Extubation	2	2
Device Embedded In Tissue or Plaque	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Unspecified Gastrointestinal Problem	1	1
Unspecified Tissue Injury	1	1
Respiratory Failure	1	1
Bronchospasm	1	1
Pulmonary Edema	1	1
Obstruction/Occlusion	1	1
Ulcer	1	1
Pressure Sores	1	1
Laceration(s) of Esophagus	1	1
Extubate	1	1
Dysphagia/ Odynophagia	1	1
Hematoma	1	1
Hypoventilation	1	1
Bruise/Contusion	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	May-29-2019
4	MEDLINE INDUSTRIES, LP - Northfield	I	Feb-25-2024
5	MEDLINE INDUSTRIES, LP - Northfield	II	Jul-21-2023
6	MEDLINE INDUSTRIES, LP - Northfield	II	Apr-14-2022
7	Sarnova HC, Llc	II	Jan-12-2024
8	SunMed Holdings, LLC	II	Jan-26-2023