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	96	96
Off-Label Use	76	85
Suction Problem	65	66
Leak/Splash	58	61
Use of Device Problem	36	37
Complete Blockage	32	32
Device Damaged Prior to Use	22	22
Deformation Due to Compressive Stress	20	21
Suction Failure	17	17
Gas/Air Leak	16	19
Insufficient Information	14	15
Decrease in Suction	13	14
Unsealed Device Packaging	11	11
Component Missing	10	11
Improper or Incorrect Procedure or Method	9	9
Inadequate or Insufficient Training	7	7
Adverse Event Without Identified Device or Use Problem	7	7
Crack	7	7
Defective Component	6	8
Disconnection	5	5
Break	5	7
Detachment of Device or Device Component	5	5
Product Quality Problem	5	5
Unexpected Color	5	5
Material Puncture/Hole	5	5
Unintended Movement	5	5
Unclear Information	5	5
Appropriate Term/Code Not Available	4	5
Fracture	4	8
Material Deformation	4	4
Material Twisted/Bent	4	6
Obstruction of Flow	4	4
Defective Device	4	4
Material Split, Cut or Torn	4	4
Malposition of Device	4	4
Fitting Problem	3	3
Inability to Auto-Fill	3	3
Loose or Intermittent Connection	3	3
Air/Gas in Device	3	3
Backflow	3	3
Material Discolored	3	6
Missing Information	3	4
No Apparent Adverse Event	3	3
Delivered as Unsterile Product	3	3
Mechanical Problem	3	3
Connection Problem	2	2
Degraded	2	2
Melted	2	2
Device Difficult to Setup or Prepare	2	2
Failure to Obtain Sample	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	433	484
Insufficient Information	64	67
Pneumothorax	27	29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	11
Pain	7	7
Hemorrhage/Bleeding	5	5
Aspiration/Inhalation	4	4
Low Oxygen Saturation	4	5
Pulmonary Emphysema	3	3
Perforation of Vessels	3	3
Distress	3	3
Unspecified Infection	2	2
Hypoxia	2	2
Bacterial Infection	2	2
Ascites	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
No Patient Involvement	1	1
Dyspnea	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