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
FLEXICARE MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
GREAT GROUP MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INTERSURGICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.
	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
Crack	25	25
Obstruction of Flow	24	24
Gas/Air Leak	24	24
Material Split, Cut or Torn	21	21
Filtration Problem	13	13
Material Separation	13	13
Leak/Splash	12	12
Use of Device Problem	12	12
Detachment of Device or Device Component	11	11
Disconnection	10	10
Pressure Problem	10	10
Break	10	10
Mechanical Problem	10	10
Device Damaged Prior to Use	8	8
Device Markings/Labelling Problem	8	8
Contamination	5	5
Loose or Intermittent Connection	4	4
Complete Blockage	4	4
Insufficient Information	4	4
Defective Component	4	4
Fluid/Blood Leak	3	3
Device Alarm System	3	3
Defective Device	3	3
Material Integrity Problem	3	3
Contamination /Decontamination Problem	3	3
Partial Blockage	3	3
Component Missing	3	3
Improper Flow or Infusion	3	3
Particulates	3	3
Moisture or Humidity Problem	3	3
No Flow	2	2
Gas Output Problem	2	2
Connection Problem	2	2
Appropriate Term/Code Not Available	2	2
Failure to Calibrate	2	2
Fracture	2	2
Component Misassembled	2	2
Material Deformation	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Infusion or Flow Problem	2	2
Excess Flow or Over-Infusion	2	2
Material Fragmentation	2	2
Failure to Deliver	2	2
Therapeutic or Diagnostic Output Failure	2	2
Material Puncture/Hole	2	2
Blocked Connection	1	1
Structural Problem	1	1
Decrease in Pressure	1	1
Environmental Compatibility Problem	1	1
Difficult to Insert	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	143	143
Low Oxygen Saturation	34	34
Insufficient Information	25	25
No Consequences Or Impact To Patient	18	18
No Patient Involvement	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Hypoventilation	3	3
Respiratory Arrest	3	3
Diminished Pulse Pressure	3	3
Cardiac Arrest	3	3
No Known Impact Or Consequence To Patient	3	3
Bradycardia	3	3
Cough	3	3
Hypoxia	3	3
Unspecified Respiratory Problem	3	3
Airway Obstruction	3	3
Respiratory Distress	2	2
Aspiration/Inhalation	2	2
Dyspnea	2	2
Respiratory Insufficiency	2	2
Ventilator Dependent	2	2
Respiratory Failure	2	2
Cyanosis	1	1
High Blood Pressure/ Hypertension	1	1
Obstruction/Occlusion	1	1
Cardiopulmonary Arrest	1	1
Capsular Contracture	1	1
Pulmonary Edema	1	1
Bronchospasm	1	1
Low Blood Pressure/ Hypotension	1	1
Distress	1	1

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