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
2018	45	45
2019	57	57
2020	110	110
2021	110	110
2022	117	117

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	121	121
Leak/Splash	52	52
Deformation Due to Compressive Stress	31	31
Device Damaged Prior to Use	26	26
Suction Problem	18	18
Decrease in Suction	15	15
Unsealed Device Packaging	14	14
Material Twisted/Bent	14	14
Break	12	12
Material Deformation	11	11
Tear, Rip or Hole in Device Packaging	11	11
Suction Failure	11	11
Adverse Event Without Identified Device or Use Problem	10	10
Gas/Air Leak	9	9
Component Missing	9	9
Backflow	9	9
Crack	9	9
Insufficient Information	9	9
Mechanical Problem	8	8
Air Leak	7	7
Detachment of Device or Device Component	7	7
Material Integrity Problem	6	6
Complete Blockage	6	6
Use of Device Problem	6	6
Defective Component	6	6
Activation, Positioning or Separation Problem	5	5
Appropriate Term/Code Not Available	5	5
Noise, Audible	4	4
Obstruction of Flow	4	4
Filling Problem	4	4
Delivered as Unsterile Product	4	4
Detachment Of Device Component	3	3
Defective Device	3	3
Connection Problem	3	3
Packaging Problem	3	3
Improper Flow or Infusion	3	3
Infusion or Flow Problem	3	3
Device Operates Differently Than Expected	3	3
Filtration Problem	2	2
Device Difficult to Maintain	2	2
Structural Problem	2	2
Collapse	2	2
Disconnection	2	2
Degraded	2	2
Improper or Incorrect Procedure or Method	2	2
Device Difficult to Setup or Prepare	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Air/Gas in Device	2	2
Illegible Information	1	1
Missing Information	1	1
Component Misassembled	1	1
Material Split, Cut or Torn	1	1
Device Fell	1	1
Decrease in Pressure	1	1
Off-Label Use	1	1
Product Quality Problem	1	1
Material Separation	1	1
Increase in Suction	1	1
Inadequate or Insufficient Training	1	1
Fitting Problem	1	1
Material Discolored	1	1
Fracture	1	1
Material Fragmentation	1	1
Labelling, Instructions for Use or Training Problem	1	1
Contamination	1	1
Burst Container or Vessel	1	1
Contamination /Decontamination Problem	1	1
Device Markings/Labelling Problem	1	1
Device Tipped Over	1	1
Malposition of Device	1	1
Patient-Device Incompatibility	1	1
Overfill	1	1
No Apparent Adverse Event	1	1
Positioning Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Device Dislodged or Dislocated	1	1
Installation-Related Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	202	202
No Consequences Or Impact To Patient	90	90
No Known Impact Or Consequence To Patient	41	41
Insufficient Information	30	30
Pneumothorax	26	26
No Information	23	23
No Patient Involvement	13	13
Unspecified Infection	5	5
No Code Available	5	5
Death	5	5
Pleural Effusion	4	4
Pneumonia	3	3
Pain	3	3
Dyspnea	3	3
Thrombosis	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Bacterial Infection	2	2
Cellulitis	1	1
Stroke/CVA	1	1
Hemoptysis	1	1
Hemorrhage/Bleeding	1	1
Myocardial Infarction	1	1
Chronic Obstructive Pulmonary Disease (COPD)	1	1
Weight Changes	1	1
Arrhythmia	1	1
Low Oxygen Saturation	1	1
Pulmonary Emphysema	1	1
Pulmonary Embolism	1	1
Cyanosis	1	1
Chest Pain	1	1
Respiratory Distress	1	1
Post Operative Wound Infection	1	1
Congestive Heart Failure	1	1
Emotional Changes	1	1
Sepsis	1	1
Pericardial Effusion	1	1
Unspecified Respiratory Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Atrium Medical Corporation	II	Nov-15-2022
2	Atrium Medical Corporation	II	Nov-25-2021
3	Atrium Medical Corporation	II	Sep-29-2021
4	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
5	Medline Industries Inc	II	Oct-22-2019
6	TELEFLEX MEDICAL INC	II	Aug-03-2020