TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Connection Problem	13	13
Material Split, Cut or Torn	7	7
Detachment of Device or Device Component	7	9
Gas/Air Leak	4	4
Break	3	3
Material Puncture/Hole	3	3
Defective Component	3	3
Patient Device Interaction Problem	3	3
Material Deformation	3	3
Failure to Seal	3	3
Leak/Splash	2	2
Incomplete or Inadequate Connection	2	2
Inflation Problem	2	2
Fracture	2	2
Device Dislodged or Dislocated	2	2
Loose or Intermittent Connection	2	2
Fitting Problem	1	1
Difficult to Open or Remove Packaging Material	1	1
Device Alarm System	1	1
Device Markings/Labelling Problem	1	1
Filling Problem	1	1
Patient-Device Incompatibility	1	1
Insufficient Information	1	1
Unsealed Device Packaging	1	1
Material Too Rigid or Stiff	1	1
Component Missing	1	1
Obstruction of Flow	1	1
Improper Flow or Infusion	1	1
Infusion or Flow Problem	1	1
Use of Incorrect Control/Treatment Settings	1	1
Delivered as Unsterile Product	1	1
Material Separation	1	1
Electrical Shorting	1	1
Inaccurate Delivery	1	1
Failure to Calibrate	1	1
Nonstandard Device	1	1
Display or Visual Feedback Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	43	45
Low Oxygen Saturation	11	11
Insufficient Information	4	4
Corneal Abrasion	2	2
Skin Inflammation/ Irritation	2	2
Hypoxia	2	2
Respiratory Insufficiency	2	2
Cyanosis	1	1
Emotional Changes	1	1
Blister	1	1
Confusion/ Disorientation	1	1
Discomfort	1	1
Choking	1	1
Eye Injury	1	1
Loss of consciousness	1	1
Lethargy	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Medline Industries, LP	II	Jan-08-2026