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	121	121
Off-Label Use	73	81
Suction Problem	64	65
Leak/Splash	61	64
Use of Device Problem	35	36
Complete Blockage	32	32
Deformation Due to Compressive Stress	31	32
Device Damaged Prior to Use	25	25
Suction Failure	23	23
Decrease in Suction	20	21
Gas/Air Leak	16	19
Material Deformation	15	15
Insufficient Information	15	16
Material Twisted/Bent	14	16
Unsealed Device Packaging	13	13
Crack	11	11
Adverse Event Without Identified Device or Use Problem	10	10
Component Missing	9	10
Improper or Incorrect Procedure or Method	9	9
Appropriate Term/Code Not Available	8	9
Inadequate or Insufficient Training	7	7
Disconnection	7	7
Detachment of Device or Device Component	6	6
Defective Component	6	8
Material Integrity Problem	6	6
Tear, Rip or Hole in Device Packaging	5	5
Unintended Movement	5	5
Unclear Information	5	5
Product Quality Problem	5	5
Unexpected Color	5	5
Activation, Positioning or Separation Problem	5	5
Obstruction of Flow	5	5
Fracture	4	8
Malposition of Device	4	4
Material Puncture/Hole	4	4
Mechanical Problem	4	4
Defective Device	4	4
Break	4	4
Material Split, Cut or Torn	4	4
Material Discolored	4	7
Missing Information	3	4
Labelling, Instructions for Use or Training Problem	3	4
Inability to Auto-Fill	3	3
Packaging Problem	3	3
Delivered as Unsterile Product	3	3
Air/Gas in Device	3	3
Backflow	3	3
Connection Problem	3	3
Fitting Problem	3	3
Melted	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	441	484
No Consequences Or Impact To Patient	73	73
Insufficient Information	65	68
Pneumothorax	29	31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	8
No Known Impact Or Consequence To Patient	7	7
Pain	7	7
Hemorrhage/Bleeding	5	5
No Information	4	4
Aspiration/Inhalation	4	4
Low Oxygen Saturation	4	5
Death	3	3
No Patient Involvement	3	3
Perforation of Vessels	3	3
Distress	3	3
Unspecified Infection	2	2
No Code Available	2	2
Pulmonary Emphysema	2	2
Hypoxia	2	2
Bacterial Infection	2	2
Stroke/CVA	1	1
Bronchial Hemorrhage	1	1
Respiratory Arrest	1	1
Pericardial Effusion	1	1
Cardiac Arrest	1	1
Cardiac Tamponade	1	1
Unspecified Blood or Lymphatic problem	1	1
Erythema	1	1
Vomiting	1	1
Laceration(s)	1	1
Choking	1	1
Pneumonia	1	1
Great Vessel Perforation	1	1
Unspecified Respiratory Problem	1	1
Respiratory Insufficiency	1	1
Low Blood Pressure/ Hypotension	1	1
Bruise/Contusion	1	1
Aspiration Pneumonitis	1	2

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
10	TELEFLEX MEDICAL INC	II	Aug-03-2020