TPLC - Total Product Life Cycle

• Device: container, specimen, sterile
• Product Code: FMH
• Regulation Number: 864.3250
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2014	26	26
2015	12	12
2016	2	2
2017	17	17
2018	45	45
2019	81	81
2020	40	40
2021	22	22
2022	20	20
2023	43	43
2024	7	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	67	67
Device Contamination with Chemical or Other Material	65	65
Incorrect, Inadequate or Imprecise Result or Readings	22	22
Short Fill	20	20
Material Rupture	12	12
Break	10	10
Difficult to Remove	10	10
Device Markings/Labelling Problem	10	10
False Positive Result	8	8
Incorrect Or Inadequate Test Results	8	8
Volume Accuracy Problem	7	7
Unsealed Device Packaging	7	7
Fluid/Blood Leak	7	7
Component Missing	6	6
Tear, Rip or Hole in Device Packaging	6	6
Improper or Incorrect Procedure or Method	5	5
Crack	5	5
Appropriate Term/Code Not Available	5	5
Separation Problem	4	4
Material Deformation	4	4
Device Operates Differently Than Expected	4	4
Defective Device	4	4
Detachment Of Device Component	4	4
Difficult to Insert	4	4
Material Separation	4	4
Coagulation in Device or Device Ingredient	3	3
Incorrect Measurement	3	3
Separation Failure	3	3
Split	2	2
Activation, Positioning or Separation Problem	2	2
Device Ingredient or Reagent Problem	2	2
Material Integrity Problem	2	2
Material Protrusion/Extrusion	2	2
Material Twisted/Bent	2	2
Compatibility Problem	2	2
Device Dislodged or Dislocated	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Fracture	2	2
Contamination	2	2
Burst Container or Vessel	2	2
Overfill	2	2
Structural Problem	1	1
Fitting Problem	1	1
Defective Component	1	1
Unraveled Material	1	1
Peeled/Delaminated	1	1
Product Quality Problem	1	1
Loose or Intermittent Connection	1	1
Material Discolored	1	1
Filling Problem	1	1
Misassembled	1	1
Nonstandard Device	1	1
Delivered as Unsterile Product	1	1
No Device Output	1	1
Infusion or Flow Problem	1	1
Device Contaminated During Manufacture or Shipping	1	1
Failure to Seal	1	1
Mechanical Jam	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Protective Measures Problem	1	1
Insufficient Information	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Device-Device Incompatibility	1	1
Difficult to Open or Close	1	1
Inadequate Instructions for Non-Healthcare Professional	1	1
Detachment of Device or Device Component	1	1
Contamination /Decontamination Problem	1	1
Connection Problem	1	1
Failure to Disconnect	1	1
Difficult or Delayed Activation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	167	167
No Clinical Signs, Symptoms or Conditions	83	83
No Consequences Or Impact To Patient	24	24
No Information	15	15
No Patient Involvement	9	9
Insufficient Information	8	8
Needle Stick/Puncture	4	4
Exposure to Body Fluids	2	2
No Code Available	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hypersensitivity/Allergic reaction	1	1
Rupture	1	1
Test Result	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Bard Medical Division	II	Aug-25-2018
2	Becton Dickinson & Company	III	Apr-04-2013
3	Centurion Medical Products Corporation	II	Feb-05-2020
4	Covidien LLC	II	Dec-14-2016
5	Customed, Inc	II	Sep-03-2015
6	Customed, Inc	I	Dec-16-2014
7	Customed, Inc	I	Aug-29-2014
8	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-29-2024
9	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-03-2023
10	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-06-2023
11	Meridian Bioscience Inc	II	Dec-08-2023
12	Thermo Fisher Scientific (Monterrey)	II	May-26-2020
13	Thermo Fisher Scientific (Monterrey)	II	Nov-01-2019