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	21	21
Device Contamination with Chemical or Other Material	14	14
Incorrect, Inadequate or Imprecise Result or Readings	10	10
Fluid/Blood Leak	8	8
Device Markings/Labelling Problem	7	7
Volume Accuracy Problem	6	6
Adverse Event Without Identified Device or Use Problem	5	5
Product Quality Problem	5	5
Device Ingredient or Reagent Problem	4	4
Break	4	4
Delivered as Unsterile Product	4	4
Detachment of Device or Device Component	3	3
Material Protrusion/Extrusion	3	3
Component Missing	3	3
Separation Problem	2	2
No Apparent Adverse Event	2	2
Material Separation	2	2
Difficult to Open or Close	2	2
Device Operates Differently Than Expected	2	2
Failure to Shut Off	1	1
Missing Information	1	1
Naturally Worn	1	1
Premature Separation	1	1
Premature Activation	1	1
Detachment Of Device Component	1	1
Insufficient Information	1	1
Contamination	1	1
Difficult to Remove	1	1
Scratched Material	1	1
Use of Device Problem	1	1
Incorrect Or Inadequate Test Results	1	1
Material Deformation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	57	57
No Known Impact Or Consequence To Patient	49	49
No Consequences Or Impact To Patient	14	14
No Patient Involvement	3	3
No Information	2	2
Needle Stick/Puncture	2	2
Insufficient Information	2	2
Hypersensitivity/Allergic reaction	1	1
No Code Available	1	1
Failure of Implant	1	1
Inflammation	1	1
Blood Loss	1	1
Reaction	1	1
Hemorrhage/Bleeding	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