TPLC - Total Product Life Cycle

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Device	bottle, collection, vacuum
Regulation Description	Vacuum-powered body fluid suction apparatus.
Product Code	KDQ
Regulation Number	880.6740
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	92	92
Off-Label Use	78	88
Suction Problem	66	67
Leak/Splash	51	53
Complete Blockage	32	32
Use of Device Problem	32	33
Device Damaged Prior to Use	22	22
Deformation Due to Compressive Stress	20	21
Suction Failure	15	15
Decrease in Suction	13	14
Gas/Air Leak	11	12
Unsealed Device Packaging	11	11
Insufficient Device Problem Information	10	11
Improper or Incorrect Procedure or Method	9	9
Adverse Event Without Identified Device or Use Problem	8	9
Inadequate or Insufficient Training	7	7
Component Missing	7	7
Break	6	8
Crack	6	6
Unintended Movement	6	6
Detachment of Device or Device Component	5	5
Disconnection	5	5
Unclear Information	5	5
Unexpected Color	5	5
Material Split, Cut or Torn	4	4
Material Deformation	4	4
Product Quality Problem	4	4
Appropriate Device Problem Term/Code Not Available	4	5
Fracture	4	8
Malposition of Device	4	4
Material Twisted/Bent	4	6
Material Puncture/Hole	3	3
Delivered as Unsterile Product	3	3
Mechanical Problem	3	3
Loose or Intermittent Connection	3	3
Obstruction of Flow	3	3
Defective Component	3	3
Missing Information	3	4
No Apparent Adverse Event	3	3
Material Discolored	3	6
Inability to Auto-Fill	3	3
Packaging Problem	2	2
Fitting Problem	2	2
Device Difficult to Maintain	2	2
Melted	2	2
Labelling, Instructions for Use or Training Problem	2	3
Degraded	2	2
Device Handling Problem	2	3
Pressure Problem	1	1
Material Integrity Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	442	497
Insufficient Information	64	67
Pneumothorax	27	29
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	10	11
Pain	7	7
Hemorrhage/Blood Loss/Bleeding	5	5
Aspiration/Inhalation	4	4
Low Oxygen Saturation	4	5
Perforation of Vessels	3	3
Distress	3	3
Pulmonary Emphysema	3	3
Hypoxia	2	2
Ascites	2	2
Unspecified Infection	2	2
Bacterial Infection	2	2
Stroke/CVA	1	1
Erythema	1	1
Pericardial Effusion	1	1
Bronchial Hemorrhage	1	1
Respiratory Arrest	1	1
Cardiac Arrest	1	1
No Patient Involvement	1	1
Bruise/Contusion	1	1
Unspecified Respiratory Problem	1	1
Cardiac Tamponade	1	1
Laceration(s)	1	1
Dyspnea	1	1
Choking	1	1
Pneumonia	1	1
Great Vessel Perforation	1	1
Aspiration Pneumonitis	1	2
Low Blood Pressure/ Hypotension	1	1
Unspecified Blood or Lymphatic problem	1	1
Respiratory Insufficiency	1	1
Vomiting	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Atrium Medical Corporation	II	Dec-02-2023
2	Atrium Medical Corporation	II	Mar-30-2023
3	Atrium Medical Corporation	II	Nov-15-2022
4	Atrium Medical Corporation	II	Nov-25-2021
5	Atrium Medical Corporation	II	Sep-29-2021
6	DeRoyal Industries Inc	II	Mar-23-2023
7	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-11-2024
8	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-22-2024
9	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022