TPLC - Total Product Life Cycle

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Device	airway, oropharyngeal, anesthesiology
Product Code	CAE
Regulation Number	868.5110
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Deflation Problem	73	73
Gas/Air Leak	57	57
Inflation Problem	51	51
Device Operates Differently Than Expected	41	41
Leak/Splash	38	38
Break	33	33
Material Separation	26	26
Adverse Event Without Identified Device or Use Problem	15	15
Detachment of Device or Device Component	13	13
Crack	11	11
Disconnection	8	8
Use of Device Problem	8	8
Deformation Due to Compressive Stress	8	8
Material Rupture	8	8
Material Split, Cut or Torn	7	7
Shelf Life Exceeded	7	7
Material Integrity Problem	7	7
Physical Resistance/Sticking	7	7
Improper or Incorrect Procedure or Method	7	7
Material Deformation	7	7
Hole In Material	6	6
Inadequacy of Device Shape and/or Size	6	6
Obstruction of Flow	6	6
Insufficient Information	6	6
Difficult to Insert	6	6
Air Leak	6	6
Appropriate Term/Code Not Available	5	5
Detachment Of Device Component	5	5
Material Protrusion/Extrusion	5	5
Device Damaged Prior to Use	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Contamination /Decontamination Problem	5	5
Misassembled	4	4
Material Too Rigid or Stiff	4	4
Fitting Problem	4	4
Device Dislodged or Dislocated	4	4
Material Puncture/Hole	4	4
Torn Material	4	4
Device Markings/Labelling Problem	4	4
Structural Problem	4	4
Sticking	4	4
Mechanical Problem	4	4
Loose or Intermittent Connection	4	4
Defective Device	4	4
Separation Problem	3	3
Positioning Problem	3	3
Material Fragmentation	3	3
Nonstandard Device	3	3
Occlusion Within Device	3	3
Fracture	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	161	161
No Consequences Or Impact To Patient	154	154
No Known Impact Or Consequence To Patient	76	76
No Patient Involvement	75	75
Insufficient Information	24	24
Extubate	12	12
No Information	9	9
Foreign Body In Patient	8	8
Low Oxygen Saturation	6	6
No Code Available	6	6
Cardiac Arrest	6	6
Death	5	5
Numbness	5	5
Sore Throat	4	4
Hemorrhage/Bleeding	4	4
Hypoxia	4	4
Cyanosis	3	3
Unintended Extubation	3	3
Airway Obstruction	3	3
Dysphagia/ Odynophagia	3	3
Injury	3	3
Device Embedded In Tissue or Plaque	2	2
Respiratory Failure	2	2
Respiratory Insufficiency	2	2
Laceration(s)	2	2
Ecchymosis	2	2
Hypoventilation	2	2
Dyspnea	1	1
Discomfort	1	1
Swelling	1	1
Pain	1	1
Obstruction/Occlusion	1	1
Pulmonary Edema	1	1
Bronchospasm	1	1
Unspecified Tissue Injury	1	1
Laceration(s) of Esophagus	1	1
Ulcer	1	1
Abrasion	1	1
Inflammation	1	1
Pressure Sores	1	1
Hematoma	1	1
Unspecified Gastrointestinal Problem	1	1
Respiratory Arrest	1	1
Respiratory Distress	1	1
Sweating	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Bruise/Contusion	1	1
Patient Problem/Medical Problem	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	Carefusion 2200 Inc	II	Sep-20-2016
4	Intersurgical Inc	II	Oct-17-2022
5	King Systems Corp.	II	Jan-10-2014
6	King Systems Corp.	II	Oct-01-2013
7	King Systems Corp.	III	Sep-19-2013
8	King Systems Corp.	II	Nov-21-2012
9	King Systems Corp.	II	Apr-04-2011
10	King Systems Corp.	II	Mar-17-2011
11	King Systems Corp.	II	Jan-27-2011
12	King Systems Corp. dba Ambu, Inc.	II	May-29-2019
13	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
14	MEDLINE INDUSTRIES, LP - Northfield	I	Feb-25-2024
15	MEDLINE INDUSTRIES, LP - Northfield	II	Jul-21-2023
16	MEDLINE INDUSTRIES, LP - Northfield	II	Apr-14-2022
17	Microtek Medical Inc	II	Jun-26-2015
18	Sarnova HC, Llc	II	Jan-12-2024
19	Sterilmed Inc	II	Jan-13-2009
20	SunMed Holdings, LLC	II	Jan-26-2023
21	Teleflex Medical	II	Feb-10-2015