TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Obstruction of Flow	493	493
Device Contamination with Chemical or Other Material	284	284
Suction Problem	154	154
Leak/Splash	136	136
Break	66	66
Material Separation	66	66
Adverse Event Without Identified Device or Use Problem	44	44
Material Integrity Problem	38	38
Device Contaminated During Manufacture or Shipping	37	37
Unraveled Material	34	34
Detachment of Device or Device Component	32	32
Fluid/Blood Leak	22	22
Activation Problem	18	18
Use of Device Problem	15	15
Material Deformation	14	14
Difficult to Remove	12	12
Entrapment of Device	11	11
Contamination /Decontamination Problem	11	11
No Flow	10	10
Suction Failure	10	10
Material Frayed	7	7
Insufficient Information	7	7
Material Twisted/Bent	7	7
Delivered as Unsterile Product	6	6
Gas/Air Leak	6	6
Material Split, Cut or Torn	5	5
Improper or Incorrect Procedure or Method	5	5
Malposition of Device	5	5
Crack	5	5
Material Puncture/Hole	5	5
Decrease in Suction	5	5
Component Missing	5	5
Deformation Due to Compressive Stress	4	4
Physical Resistance/Sticking	4	4
Patient Device Interaction Problem	4	4
Fracture	3	3
No Apparent Adverse Event	3	3
Partial Blockage	3	3
Disconnection	3	3
Fitting Problem	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Separation Problem	3	3
Device Damaged Prior to Use	3	3
Backflow	2	2
Defective Component	2	2
Inaccurate Information	2	2
Sharp Edges	2	2
Difficult to Advance	2	2
Complete Blockage	2	2
Device Markings/Labelling Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	838	838
No Patient Involvement	314	314
No Consequences Or Impact To Patient	222	222
Insufficient Information	57	57
Pneumothorax	35	35
Foreign Body In Patient	30	30
No Code Available	16	16
No Known Impact Or Consequence To Patient	14	14
Hemorrhage/Bleeding	10	10
Unspecified Infection	9	9
Pain	7	7
Internal Organ Perforation	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Failure to Anastomose	6	6
Not Applicable	6	6
Swelling	6	6
Seroma	6	6
Air Embolism	5	5
Bradycardia	5	5
Pleural Effusion	5	5
Inflammation	5	5
Reaction	4	4
Cardiac Tamponade	4	4
Hematoma	4	4
Fistula	3	3
Device Embedded In Tissue or Plaque	3	3
Pulmonary Emphysema	3	3
Low Oxygen Saturation	3	3
Necrosis	3	3
No Information	3	3
Airway Obstruction	3	3
Laceration(s)	3	3
Pneumonia	3	3
Death	3	3
Swelling/ Edema	3	3
Cardiac Perforation	2	2
Needle Stick/Puncture	2	2
Impaired Healing	2	2
Chest Pain	2	2
Respiratory Distress	2	2
Dyspnea	2	2
Loss of consciousness	2	2
Adult Respiratory Distress Syndrome	2	2
Abdominal Pain	2	2
Unspecified Tissue Injury	2	2
Distress	1	1
Hemothorax	1	1
Respiratory Failure	1	1
Low Blood Pressure/ Hypotension	1	1
Bacterial Infection	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cardinal Health 200, LLC	I	Feb-16-2024
2	ConvaTec, Inc	II	Mar-21-2019
3	Cook Inc.	II	Nov-21-2019
4	MEDLINE INDUSTRIES, LP - Northfield	I	Feb-25-2024
5	MEDLINE INDUSTRIES, LP - Northfield	II	Jul-20-2023
6	Merit Medical Systems, Inc.	II	Aug-12-2024
7	Santanello Surgical LLC	II	Aug-09-2019
8	Teleflex Medical	II	Feb-16-2019