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
AMBU A/S
	SUBSTANTIALLY EQUIVALENT	1
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 AS
	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	53	53
Use of Device Problem	31	31
Crack	30	30
Obstruction of Flow	29	31
Material Split, Cut or Torn	28	28
Loose or Intermittent Connection	16	16
Break	15	15
Leak/Splash	14	15
Filtration Problem	14	14
Material Separation	14	14
Disconnection	11	12
Detachment of Device or Device Component	11	11
Pressure Problem	10	11
Mechanical Problem	10	12
Connection Problem	10	10
Device Damaged Prior to Use	8	8
Device Markings/Labelling Problem	8	8
Material Puncture/Hole	8	8
Contamination	6	6
Material Integrity Problem	5	5
Device Alarm System	4	4
Complete Blockage	4	4
Insufficient Information	4	4
Failure to Calibrate	4	4
Defective Component	4	4
Component Misassembled	4	4
Fluid/Blood Leak	3	3
Appropriate Term/Code Not Available	3	3
Fracture	3	3
Partial Blockage	3	3
Moisture or Humidity Problem	3	3
Infusion or Flow Problem	3	3
Particulates	3	3
Improper Flow or Infusion	3	3
Component Missing	3	3
Contamination /Decontamination Problem	3	3
Defective Device	3	3
Excess Flow or Over-Infusion	2	2
Material Fragmentation	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Sharp Edges	2	2
Material Deformation	2	2
Failure to Deliver	2	2
Tear, Rip or Hole in Device Packaging	2	2
Therapeutic or Diagnostic Output Failure	2	2
Tidal Volume Fluctuations	2	3
Gas Output Problem	2	2
No Flow	2	3
Device Difficult to Setup or Prepare	1	1
Difficult to Insert	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	222	223
Low Oxygen Saturation	37	38
Insufficient Information	29	29
No Consequences Or Impact To Patient	18	18
No Patient Involvement	7	8
Unspecified Respiratory Problem	4	4
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
Dyspnea	3	3
Bradycardia	3	4
Cough	3	4
Hypoxia	3	3
Airway Obstruction	3	3
Respiratory Distress	2	2
Aspiration/Inhalation	2	2
Respiratory Insufficiency	2	2
Ventilator Dependent	2	2
Respiratory Failure	2	2
Cyanosis	1	1
High Blood Pressure/ Hypertension	1	2
Apnea	1	1
Death	1	1
Brain Injury	1	1
Abrasion	1	1
Obstruction/Occlusion	1	1
Cardiopulmonary Arrest	1	1
Capsular Contracture	1	1
Pulmonary Edema	1	2
Bronchospasm	1	1
Unspecified Tissue Injury	1	1
Hemorrhage/Bleeding	1	1
Low Blood Pressure/ Hypotension	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