TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Obstruction of Flow	463	463
Device Contamination with Chemical or Other Material	284	284
Suction Problem	154	154
Leak/Splash	126	126
Break	62	62
Material Separation	60	60
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	29	29
Fluid/Blood Leak	22	22
Activation Problem	16	16
Material Deformation	14	14
Use of Device Problem	14	14
Difficult to Remove	12	12
Entrapment of Device	11	11
Contamination /Decontamination Problem	10	10
Suction Failure	10	10
No Flow	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
Crack	5	5
Decrease in Suction	5	5
Material Puncture/Hole	5	5
Improper or Incorrect Procedure or Method	5	5
Fitting Problem	4	4
Physical Resistance/Sticking	4	4
Component Missing	4	4
Fracture	3	3
No Apparent Adverse Event	3	3
Partial Blockage	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Disconnection	3	3
Separation Problem	3	3
Device Damaged Prior to Use	3	3
Defective Component	2	2
Backflow	2	2
Complete Blockage	2	2
Deformation Due to Compressive Stress	2	2
Inaccurate Information	2	2
Difficult to Advance	2	2
Sharp Edges	2	2
Device Markings/Labelling Problem	2	2
Output Problem	2	2
Air/Gas in Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	782	782
No Patient Involvement	314	314
No Consequences Or Impact To Patient	222	222
Insufficient Information	47	47
Pneumothorax	31	31
Foreign Body In Patient	27	27
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
Failure to Anastomose	6	6
Swelling	6	6
Seroma	6	6
Air Embolism	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Bradycardia	5	5
Inflammation	5	5
Internal Organ Perforation	4	4
Reaction	4	4
Hematoma	4	4
Cardiac Tamponade	4	4
Fistula	3	3
Device Embedded In Tissue or Plaque	3	3
Low Oxygen Saturation	3	3
Swelling/ Edema	3	3
Pneumonia	3	3
Laceration(s)	3	3
Pleural Effusion	3	3
Pulmonary Emphysema	3	3
Necrosis	3	3
No Information	3	3
Death	3	3
Cardiac Perforation	2	2
Chest Pain	2	2
Dyspnea	2	2
Unspecified Tissue Injury	2	2
Respiratory Distress	2	2
Adult Respiratory Distress Syndrome	2	2
Loss of consciousness	2	2
Airway Obstruction	2	2
Abdominal Pain	2	2
Impaired Healing	2	2
Fever	1	1
Needle Stick/Puncture	1	1
Injury	1	1
Cardiac Arrest	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Obstruction/Occlusion	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