TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	20	20
Break	14	14
Insufficient Information	14	14
Adverse Event Without Identified Device or Use Problem	12	12
Detachment of Device or Device Component	7	7
Air/Gas in Device	3	4
Fail-Safe Problem	3	3
Material Deformation	3	3
Material Protrusion/Extrusion	3	3
Labelling, Instructions for Use or Training Problem	2	2
Leak/Splash	1	1
Device Contaminated During Manufacture or Shipping	1	1
Material Split, Cut or Torn	1	1
Separation Problem	1	1
Crack	1	1
Material Puncture/Hole	1	1
Defective Component	1	1
Material Integrity Problem	1	1
Difficult to Remove	1	1
Material Twisted/Bent	1	1
Material Separation	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	38	38
Hemorrhage/Bleeding	21	21
Foreign Body In Patient	13	13
Insufficient Information	8	8
Hematoma	2	2
Needle Stick/Puncture	2	2
Encephalopathy	1	1
Dysphasia	1	1
Hematuria	1	1
Obstruction/Occlusion	1	1
Cardiac Arrest	1	1
Exposure to Body Fluids	1	1
Discomfort	1	1
Hypoxia	1	1
Headache	1	1
Thromboembolism	1	1
Low Blood Pressure/ Hypotension	1	2
Ventilator Dependent	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Edwards Lifesciences, LLC	I	Jul-10-2025