TPLC - Total Product Life Cycle

• Device: bottle, collection, vacuum
• Product Code: KDQ
• Regulation Number: 880.6740
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2014	43	43
2015	34	34
2016	77	77
2017	53	53
2018	45	45
2019	57	57
2020	110	110
2021	110	110
2022	118	118
2023	92	92
2024	124	124

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	140	140
Suction Problem	88	88
Leak/Splash	71	71
Off-Label Use	56	56
Complete Blockage	34	34
Break	33	33
Deformation Due to Compressive Stress	31	31
Device Operates Differently Than Expected	30	30
Device Damaged Prior to Use	28	28
Decrease in Suction	24	24
Crack	24	24
Use of Device Problem	21	21
Air Leak	21	21
Suction Failure	20	20
Material Deformation	17	17
Adverse Event Without Identified Device or Use Problem	17	17
Component Missing	16	16
Unsealed Device Packaging	16	16
Insufficient Information	16	16
Material Twisted/Bent	15	15
Tear, Rip or Hole in Device Packaging	14	14
Burst Container or Vessel	14	14
Gas/Air Leak	13	13
Appropriate Term/Code Not Available	12	12
Disconnection	12	12
Collapse	11	11
Material Separation	11	11
Material Integrity Problem	11	11
Connection Problem	10	10
Detachment of Device or Device Component	10	10
Backflow	10	10
Loose or Intermittent Connection	9	9
Mechanical Problem	9	9
Inadequate or Insufficient Training	8	8
Obstruction of Flow	8	8
Improper or Incorrect Procedure or Method	7	7
Kinked	7	7
Fitting Problem	7	7
Noise, Audible	6	6
Filling Problem	6	6
Defective Component	6	6
Unintended Movement	5	5
Activation, Positioning or Separation Problem	5	5
Fracture	5	5
Unclear Information	5	5
Product Quality Problem	5	5
Contamination	5	5
Device Slipped	4	4
Unexpected Color	4	4
Delivered as Unsterile Product	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	377	377
No Consequences Or Impact To Patient	135	135
No Known Impact Or Consequence To Patient	117	117
Insufficient Information	54	54
Pneumothorax	48	48
No Information	43	43
No Patient Involvement	28	28
No Code Available	15	15
Pain	9	9
Death	7	7
Dyspnea	7	7
Unspecified Infection	6	6
Low Oxygen Saturation	6	6
Aspiration/Inhalation	5	5
Thrombosis	4	4
Pleural Effusion	4	4
Distress	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Pneumonia	3	3
Respiratory Distress	3	3
Pulmonary Emphysema	3	3
Hemorrhage/Bleeding	2	2
Bacterial Infection	2	2
Post Operative Wound Infection	2	2
Foreign body, removal of	2	2
Patient Problem/Medical Problem	2	2
Cyanosis	2	2
Blood Loss	1	1
Pericardial Effusion	1	1
Cardiac Arrest	1	1
Cellulitis	1	1
Cardiac Tamponade	1	1
Chronic Obstructive Pulmonary Disease (COPD)	1	1
Hemoptysis	1	1
Unspecified Blood or Lymphatic problem	1	1
Cardiac Perforation	1	1
Foreign Body In Patient	1	1
Exposure to Body Fluids	1	1
Chest Pain	1	1
Cyst(s)	1	1
Test Result	1	1
Vomiting	1	1
Necrosis	1	1
Respiratory Arrest	1	1
Not Applicable	1	1
Laceration(s)	1	1
Sepsis	1	1
Emotional Changes	1	1
Congestive Heart Failure	1	1
Embolism	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	Atrium Medical Corporation	II	Feb-15-2017
7	Atrium Medical Corporation	II	Aug-20-2013
8	DeRoyal Industries Inc	II	Mar-23-2023
9	DeRoyal Industries Inc	II	Oct-20-2014
10	DeRoyal Industries Inc	II	Oct-20-2010
11	Hologic, Inc	II	Jul-19-2016
12	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-11-2024
13	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-22-2024
14	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
15	Medline Industries Inc	II	Oct-22-2019
16	Medline Industries Inc	II	Nov-03-2016
17	Ohio Medical Corporation	II	Oct-29-2009
18	Stryker Sustainability Solutions	I	Jan-04-2016
19	TELEFLEX MEDICAL INC	II	Aug-03-2020
20	Teleflex Medical	II	Apr-08-2015