TPLC - Total Product Life Cycle

show TPLC since

Device Problems	MDRs with this Device Problem	Events in those MDRs
Obstruction of Flow	473	473
Device Contamination with Chemical or Other Material	284	284
Suction Problem	154	154
Leak/Splash	130	130
Break	64	64
Material Separation	62	62
Adverse Event Without Identified Device or Use Problem	42	42
Material Integrity Problem	37	37
Device Contaminated During Manufacture or Shipping	35	35
Unraveled Material	33	33
Detachment of Device or Device Component	30	30
Fluid/Blood Leak	22	22
Activation Problem	17	17
Material Deformation	14	14
Use of Device Problem	14	14
Difficult to Remove	12	12
Entrapment of Device	11	11
Contamination /Decontamination Problem	11	11
Suction Failure	10	10
No Flow	10	10
Insufficient Information	7	7
Material Twisted/Bent	7	7
Material Frayed	7	7
Delivered as Unsterile Product	6	6
Gas/Air Leak	6	6
Material Split, Cut or Torn	5	5
Crack	5	5
Decrease in Suction	5	5
Material Puncture/Hole	5	5
Improper or Incorrect Procedure or Method	5	5
Physical Resistance/Sticking	4	4
Component Missing	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Separation Problem	3	3
No Apparent Adverse Event	3	3
Fitting Problem	3	3
Device Damaged Prior to Use	3	3
Disconnection	3	3
Fracture	3	3
Partial Blockage	3	3
Backflow	2	2
Complete Blockage	2	2
Defective Component	2	2
Output Problem	2	2
Inaccurate Information	2	2
Sharp Edges	2	2
Deformation Due to Compressive Stress	2	2
Device Markings/Labelling Problem	2	2
Difficult to Advance	2	2
Difficult to Open or Remove Packaging Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	801	801
No Patient Involvement	314	314
No Consequences Or Impact To Patient	222	222
Insufficient Information	47	47
Pneumothorax	31	31
Foreign Body In Patient	29	29
No Code Available	16	16
No Known Impact Or Consequence To Patient	14	14
Unspecified Infection	9	9
Hemorrhage/Bleeding	9	9
Pain	7	7
Not Applicable	6	6
Seroma	6	6
Failure to Anastomose	6	6
Swelling	6	6
Air Embolism	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Inflammation	5	5
Bradycardia	5	5
Internal Organ Perforation	4	4
Hematoma	4	4
Reaction	4	4
Cardiac Tamponade	4	4
Device Embedded In Tissue or Plaque	3	3
Fistula	3	3
Death	3	3
Low Oxygen Saturation	3	3
Necrosis	3	3
No Information	3	3
Pulmonary Emphysema	3	3
Swelling/ Edema	3	3
Pneumonia	3	3
Laceration(s)	3	3
Pleural Effusion	3	3
Airway Obstruction	2	2
Loss of consciousness	2	2
Unspecified Tissue Injury	2	2
Dyspnea	2	2
Chest Pain	2	2
Cardiac Perforation	2	2
Respiratory Distress	2	2
Adult Respiratory Distress Syndrome	2	2
Impaired Healing	2	2
Abdominal Pain	2	2
Exposure to Body Fluids	1	1
Needle Stick/Puncture	1	1
Injury	1	1
Ecchymosis	1	1
Fever	1	1
Cardiac Arrest	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