TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	28	28
Short Fill	14	14
Device Contamination with Chemical or Other Material	14	14
Incorrect, Inadequate or Imprecise Result or Readings	9	9
Fluid/Blood Leak	8	8
Volume Accuracy Problem	6	6
Device Markings/Labelling Problem	5	5
Delivered as Unsterile Product	4	4
Break	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Material Protrusion/Extrusion	3	3
Detachment of Device or Device Component	3	3
Device Ingredient or Reagent Problem	3	3
Component Missing	3	3
Device Operates Differently Than Expected	2	2
Difficult to Open or Close	2	2
Product Quality Problem	2	2
No Apparent Adverse Event	2	2
Insufficient Information	1	1
Separation Problem	1	1
Premature Separation	1	1
Missing Information	1	1
Naturally Worn	1	1
Scratched Material	1	1
Difficult to Remove	1	1
Material Separation	1	1
Detachment Of Device Component	1	1
Contamination	1	1
Premature Activation	1	1
Failure to Shut Off	1	1
Incorrect Or Inadequate Test Results	1	1
Use of Device Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	49	49
No Clinical Signs, Symptoms or Conditions	40	40
No Consequences Or Impact To Patient	14	14
No Patient Involvement	3	3
No Information	2	2
No Code Available	1	1
Reaction	1	1
Needle Stick/Puncture	1	1
Blood Loss	1	1
Hemorrhage/Bleeding	1	1
Hypersensitivity/Allergic reaction	1	1
Failure of Implant	1	1
Inflammation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Becton Dickinson & Company	II	Nov-21-2018
2	Becton Dickinson & Company	III	Mar-08-2010
3	Hologic, Inc	II	Mar-11-2022
4	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022