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
2019	57	57
2020	110	110
2021	110	110
2022	118	118
2023	92	92
2024	63	63

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	123	123
Leak/Splash	52	52
Off-Label Use	48	48
Complete Blockage	32	32
Suction Problem	31	31
Deformation Due to Compressive Stress	31	31
Device Damaged Prior to Use	25	25
Decrease in Suction	21	21
Use of Device Problem	18	18
Material Twisted/Bent	15	15
Suction Failure	14	14
Unsealed Device Packaging	14	14
Component Missing	13	13
Gas/Air Leak	13	13
Tear, Rip or Hole in Device Packaging	12	12
Material Deformation	11	11
Crack	9	9
Break	9	9
Adverse Event Without Identified Device or Use Problem	8	8
Insufficient Information	8	8
Appropriate Term/Code Not Available	7	7
Detachment of Device or Device Component	7	7
Disconnection	7	7
Mechanical Problem	7	7
Inadequate or Insufficient Training	6	6
Defective Component	6	6
Obstruction of Flow	6	6
Material Integrity Problem	6	6
Unintended Movement	5	5
Activation, Positioning or Separation Problem	5	5
Product Quality Problem	5	5
Filling Problem	5	5
Unclear Information	5	5
Delivered as Unsterile Product	4	4
Improper or Incorrect Procedure or Method	4	4
Defective Device	4	4
Noise, Audible	4	4
Packaging Problem	3	3
Connection Problem	3	3
Infusion or Flow Problem	3	3
Fitting Problem	3	3
Inability to Auto-Fill	3	3
Backflow	3	3
Material Split, Cut or Torn	3	3
Air/Gas in Device	3	3
Missing Information	2	2
Degraded	2	2
Material Fragmentation	2	2
Material Puncture/Hole	2	2
Device Difficult to Setup or Prepare	2	2
Improper Flow or Infusion	2	2
Contamination /Decontamination Problem	2	2
Filtration Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Device Difficult to Maintain	2	2
Device Handling Problem	2	2
No Apparent Adverse Event	1	1
Patient Device Interaction Problem	1	1
Component Misassembled	1	1
Illegible Information	1	1
Pressure Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Overfill	1	1
Device Tipped Over	1	1
Malposition of Device	1	1
Patient-Device Incompatibility	1	1
Inadequate Instructions for Non-Healthcare Professional	1	1
Installation-Related Problem	1	1
Device Markings/Labelling Problem	1	1
Device Dislodged or Dislocated	1	1
Decrease in Pressure	1	1
Melted	1	1
Material Separation	1	1
Increase in Suction	1	1
Labelling, Instructions for Use or Training Problem	1	1
Loose or Intermittent Connection	1	1
Fracture	1	1
Material Discolored	1	1
Partial Blockage	1	1
Burst Container or Vessel	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	327	327
No Consequences Or Impact To Patient	85	85
Insufficient Information	44	44
No Known Impact Or Consequence To Patient	35	35
Pneumothorax	27	27
No Information	9	9
No Patient Involvement	8	8
Pain	7	7
Death	3	3
No Code Available	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Distress	3	3
Low Oxygen Saturation	2	2
Unspecified Infection	2	2
Aspiration/Inhalation	2	2
Bacterial Infection	2	2
Cardiac Arrest	1	1
Stroke/CVA	1	1
Cyanosis	1	1
Dyspnea	1	1
Hypoxia	1	1
Pneumonia	1	1
Unspecified Blood or Lymphatic problem	1	1
Aspiration Pneumonitis	1	1
Respiratory Arrest	1	1
Respiratory Insufficiency	1	1
Unspecified Respiratory Problem	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	DeRoyal Industries Inc	II	Mar-23-2023
7	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
8	Medline Industries Inc	II	Oct-22-2019
9	TELEFLEX MEDICAL INC	II	Aug-03-2020