TPLC - Total Product Life Cycle

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Device	filter, bacterial, breathing-circuit
Regulation Description	Breathing circuit bacterial filter.
Product Code	CAH
Regulation Number	868.5260
Device Class	2

Premarket Reviews
Manufacturer	Decision
BESMED HEALTH BUSINESS CORP
	SUBSTANTIALLY EQUIVALENT	1
DRÄGERWERK AG & CO KGAA
	SUBSTANTIALLY EQUIVALENT	1
GREAT GROUP MEDICAL CO, LTD.
	SUBSTANTIALLY EQUIVALENT	1
INTERSURGICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	1
NDD MEDIZINTECHNIK AG
	SUBSTANTIALLY EQUIVALENT	1
NINGBO HUAKUN MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PALL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
PASSY-MUIR, INC.
	SUBSTANTIALLY EQUIVALENT	1
PHARMA SYSTEM AB
	SUBSTANTIALLY EQUIVALENT	1
SHAOXING HAITECH MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	46	46
Crack	28	28
Material Split, Cut or Torn	28	28
Use of Device Problem	26	26
Obstruction of Flow	23	25
Break	15	15
Loose or Intermittent Connection	13	13
Filtration Problem	12	12
Material Separation	12	12
Disconnection	10	11
Leak/Splash	10	10
Mechanical Problem	9	10
Device Markings/Labelling Problem	8	8
Device Damaged Prior to Use	8	8
Material Puncture/Hole	8	8
Pressure Problem	8	9
Connection Problem	7	7
Detachment of Device or Device Component	6	6
Contamination	5	5
Material Integrity Problem	4	4
Insufficient Information	4	4
Component Misassembled	4	4
Complete Blockage	4	4
Failure to Calibrate	4	4
Particulates	3	3
Moisture or Humidity Problem	3	3
Improper Flow or Infusion	3	3
Fracture	3	3
Defective Component	3	3
Component Missing	3	3
Partial Blockage	3	3
Device Alarm System	3	3
Defective Device	3	3
Adverse Event Without Identified Device or Use Problem	2	2
No Flow	2	3
Therapeutic or Diagnostic Output Failure	2	2
Material Deformation	2	2
Infusion or Flow Problem	2	2
Appropriate Term/Code Not Available	2	2
Sharp Edges	2	2
Contamination /Decontamination Problem	2	2
Tear, Rip or Hole in Device Packaging	2	2
Failure to Deliver	2	2
Tidal Volume Fluctuations	2	3
Excess Flow or Over-Infusion	2	2
Gas Output Problem	2	2
Material Fragmentation	2	2
Fluid/Blood Leak	2	2
Decreased Sensitivity	1	1
Structural Problem	1	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	207	208
Low Oxygen Saturation	34	35
Insufficient Information	27	27
No Consequences Or Impact To Patient	8	8
Respiratory Arrest	3	3
Diminished Pulse Pressure	3	3
Cardiac Arrest	3	3
Bradycardia	3	4
Cough	3	4
Hypoxia	3	3
Unspecified Respiratory Problem	3	3
Airway Obstruction	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Hypoventilation	2	2
Aspiration/Inhalation	2	2
Dyspnea	2	2
Respiratory Insufficiency	2	2
Ventilator Dependent	2	2
High Blood Pressure/ Hypertension	1	2
Cyanosis	1	1
Apnea	1	1
Brain Injury	1	1
Obstruction/Occlusion	1	1
Abrasion	1	1
Cardiopulmonary Arrest	1	1
Pulmonary Edema	1	2
Capsular Contracture	1	1
Bronchospasm	1	1
Unspecified Tissue Injury	1	1
Hemorrhage/Bleeding	1	1
Distress	1	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Covidien, LP	II	Jun-16-2021
2	Draeger Medical, Inc.	I	Jun-10-2022
3	Draeger, Inc.	I	Jul-31-2025
4	Kung Shin Plastics Co. Ltd.	II	Mar-04-2025
5	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
6	Medline Industries, LP	I	Nov-13-2025
7	S & MOHR AMERICA, S.A. DE C.V.	III	Feb-22-2023
8	Smiths Medical ASD Inc.	II	Aug-28-2023
9	TELEFLEX LLC	I	Oct-14-2022