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
2017	53	53
2018	45	45
2019	57	57
2020	110	110
2021	108	108
2022	72	72

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid Leak	116	116
Leak/Splash	38	38
Suction Problem	29	29
Device Damaged Prior to Use	27	27
Unsealed Device Packaging	16	16
Break	15	15
Decrease in Suction	15	15
Deformation Due to Compressive Stress	14	14
Tear, Rip or Hole in Device Packaging	13	13
Component Missing	11	11
Material Twisted/Bent	11	11
Adverse Event Without Identified Device or Use Problem	11	11
Material Deformation	11	11
Suction Failure	11	11
Insufficient Information	10	10
Material Integrity Problem	9	9
Burst Container or Vessel	9	9
Air Leak	8	8
Backflow	8	8
Crack	8	8
Detachment of Device or Device Component	8	8
Device Operates Differently Than Expected	8	8
Mechanical Problem	6	6
Appropriate Term/Code Not Available	6	6
Complete Blockage	5	5
Activation, Positioning or SeparationProblem	5	5
Gas Leak	5	5
Filling Problem	4	4
Obstruction of Flow	4	4
Collapse	4	4
Delivered as Unsterile Product	4	4
Use of Device Problem	4	4
Noise, Audible	4	4
Detachment Of Device Component	3	3
Improper Flow or Infusion	3	3
Infusion or Flow Problem	3	3
Filtration Problem	2	2
Device Difficult to Maintain	2	2
Packaging Problem	2	2
Structural Problem	2	2
Defective Device	2	2
Malposition of Device	2	2
Connection Problem	2	2
Contamination	2	2
Disconnection	2	2
Material Fragmentation	2	2
Device Markings/Labelling 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
Labelling, Instructions for Use or Training Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Defective Component	1	1
Fitting Problem	1	1
Failure to Run on Battery	1	1
Difficult To Position	1	1
Failure to Power Up	1	1
Device Difficult to Setup or Prepare	1	1
Product Quality Problem	1	1
Material Rupture	1	1
Material Separation	1	1
Shelf Life Exceeded	1	1
Sticking	1	1
Inadequate or Insufficient Training	1	1
Flushing Problem	1	1
Occlusion Within Device	1	1
Material Discolored	1	1
Chemical Spillage	1	1
Contamination /Decontamination Problem	1	1
Device Packaging Compromised	1	1
Device Dislodged or Dislocated	1	1
Expulsion	1	1
Aspiration Issue	1	1
Physical Resistance	1	1
Overfill	1	1
Positioning Problem	1	1
No Apparent Adverse Event	1	1
Device Contamination with Chemical or Other Material	1	1
Device Contamination With Biological Material	1	1
Installation-Related Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	165	165
No Consequences Or Impact To Patient	109	109
No Known Impact Or Consequence To Patient	57	57
Pneumothorax	25	25
Insufficient Information	24	24
No Information	24	24
No Patient Involvement	19	19
No Code Available	7	7
Death	5	5
Pleural Effusion	4	4
Unspecified Infection	3	3
Dyspnea	3	3
Pain	3	3
Thrombosis	2	2
Patient Problem/Medical Problem	2	2
Bacterial Infection	2	2
Pneumonia	2	2
Respiratory Distress	1	1
Sepsis	1	1
Myocardial Infarction	1	1
Pulmonary Embolism	1	1
Arrhythmia	1	1
Aspiration/Inhalation	1	1
Cellulitis	1	1
Stroke/CVA	1	1
Chest Pain	1	1
Congestive Heart Failure	1	1
Cyanosis	1	1
Cyst(s)	1	1
Emotional Changes	1	1
Pulmonary Emphysema	1	1
Hemoptysis	1	1
Hemorrhage/Bleeding	1	1
Chronic Obstructive Pulmonary Disease (COPD)	1	1
Post Operative Wound Infection	1	1
Weight Changes	1	1
Pericardial Effusion	1	1
Unspecified Respiratory Problem	1	1
Not Applicable	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Atrium Medical Corporation	II	Nov-25-2021
2	Atrium Medical Corporation	II	Sep-29-2021
3	Atrium Medical Corporation	II	Feb-15-2017
4	Medline Industries Inc	II	Oct-22-2019
5	TELEFLEX MEDICAL INC	II	Aug-03-2020