TPLC - Total Product Life Cycle

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Device	circuit, breathing (w connector, adaptor, y piece)
Regulation Description	Anesthesia breathing circuit.
Product Code	CAI
Regulation Number	868.5240
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	269	269
Leak/Splash	153	153
Material Puncture/Hole	52	52
Loose or Intermittent Connection	36	37
Break	35	35
Connection Problem	30	30
Crack	29	29
Defective Component	20	20
Obstruction of Flow	20	20
Material Deformation	19	19
Component Missing	19	19
Material Integrity Problem	18	18
Material Split, Cut or Torn	17	17
Disconnection	15	15
Failure to Deliver	14	14
Fluid/Blood Leak	13	13
Contamination /Decontamination Problem	13	13
Detachment of Device or Device Component	12	12
Fracture	12	12
Insufficient Device Problem Information	12	12
Inflation Problem	12	12
Incomplete or Missing Packaging	9	9
Incomplete or Inadequate Connection	8	8
Material Twisted/Bent	7	7
Defective Device	7	7
Fitting Problem	7	7
Tear, Rip or Hole in Device Packaging	6	6
Device Damaged Prior to Use	6	6
Material Separation	6	6
Pressure Problem	6	6
Moisture Damage	5	5
Delivered as Unsterile Product	4	4
Material Fragmentation	4	4
Contamination	4	4
Material Perforation	4	4
Inadequacy of Device Shape and/or Size	4	4
Moisture or Humidity Problem	4	4
Complete Blockage	4	4
Device Slipped	4	4
Output Problem	4	4
Appropriate Device Problem Term/Code Not Available	3	3
Unintended Movement	3	3
Infusion or Flow Problem	3	3
Failure to Disconnect	3	3
Deformation Due to Compressive Stress	3	3
Air/Gas in Device	3	3
Device Damaged Prior to Receipt by User	3	3
Blocked Connection	3	3
Device Alarm System	3	3
Improper Flow or Infusion	3	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	776	779
Insufficient Information	87	88
Low Oxygen Saturation	12	12
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	10	10
Unspecified Infection	8	8
No Patient Involvement	7	7
Hypoventilation	6	6
No Consequences Or Impact To Patient	6	6
Respiratory Insufficiency	4	4
Ventilator Dependent	4	4
Hypoxia	3	3
Respiratory Arrest	2	2
Pain	2	2
Viral Infection	2	2
Bacterial Infection	2	2
Decreased Respiratory Rate	1	1
Discomfort	1	1
Malaise	1	1
Dyspnea	1	1
Respiratory Distress Syndrome of Newborns	1	1
Balance Problems	1	1
Foreign Body In Patient	1	1
Pulmonary Hypertension	1	1
Unspecified Respiratory Problem	1	1
Increased Respiratory Rate	1	1
Aspiration/Inhalation	1	1
Airway Obstruction	1	1
Bradycardia	1	1
Inflammation	1	1
Irritability	1	1
Burn(s)	1	1
Arrhythmia	1	1
Abnormal mucus discharge	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Draeger Medical, Inc.	I	May-17-2023
2	Draeger, Inc.	I	Apr-03-2025
3	MEDLINE INDUSTRIES, LP - Northfield	I	Sep-19-2025
4	MEDLINE INDUSTRIES, LP - Northfield	II	Apr-17-2025
5	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-19-2025
6	MEDLINE INDUSTRIES, LP - Northfield	II	Oct-23-2024
7	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-11-2024
8	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
9	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-28-2024
10	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-22-2024
11	MEDLINE INDUSTRIES, LP - Northfield	II	Jun-28-2024
12	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-03-2023
13	MEDLINE INDUSTRIES, LP - Northfield	II	Jul-20-2023
14	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-06-2023
15	Medline Industries, LP	II	Jul-08-2026
16	Medline Industries, LP	II	Jun-26-2026
17	Medline Industries, LP	I	Jun-24-2026
18	Medline Industries, LP	I	May-28-2026
19	Medline Industries, LP	II	May-07-2026
20	Medline Industries, LP	II	Apr-30-2026
21	Medline Industries, LP	II	Apr-01-2026
22	Medline Industries, LP	II	Feb-17-2026
23	Medline Industries, LP	II	Feb-09-2026
24	Medline Industries, LP	II	Feb-06-2026
25	Medline Industries, LP	II	Jan-12-2026
26	Medline Industries, LP	I	Nov-13-2025