TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ELCAM MEDICAL A.C.A.L.
	SUBSTANTIALLY EQUIVALENT	1
EMED TECHNOLOGIES CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC MINIMED
	SUBSTANTIALLY EQUIVALENT	1
OWEN MUMFORD, LTD.
	SUBSTANTIALLY EQUIVALENT	1
SCANDINAVIAN HEALTH LIMITED
	SUBSTANTIALLY EQUIVALENT	2
YPSOMED AG
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended Ejection	326	326
Misfire	195	195
Break	47	47
Bent	42	42
Sticking	33	33
Device Operates Differently Than Expected	32	32
Defective Device	25	25
Failure to Deliver	22	22
Insufficient Information	18	18
Physical Resistance/Sticking	17	17
Mechanical Jam	16	16
Adverse Event Without Identified Device or Use Problem	13	13
Device Displays Incorrect Message	13	13
Defective Component	13	13
Therapeutic or Diagnostic Output Failure	12	12
Difficult to Insert	12	12
Fluid/Blood Leak	10	10
Leak/Splash	9	9
Material Twisted/Bent	9	9
Improper or Incorrect Procedure or Method	9	9
Output Problem	8	8
Component Missing	7	7
Mechanical Problem	6	6
Fitting Problem	5	5
Activation, Positioning or Separation Problem	5	5
Inaccurate Delivery	5	5
Device Inoperable	5	5
Kinked	5	5
Patient-Device Incompatibility	5	5
High Test Results	4	4
Use of Device Problem	4	4
Occlusion Within Device	4	4
Device Alarm System	4	4
Detachment Of Device Component	4	4
Ejection Problem	3	3
Failure To Adhere Or Bond	3	3
Difficult to Remove	3	3
Appropriate Term/Code Not Available	3	3
Dull, Blunt	3	3
Failure to Infuse	3	3
Device Slipped	3	3
Key or Button Unresponsive/not Working	2	2
Air Leak	2	2
Shipping Damage or Problem	2	2
Positioning Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Crack	2	2
Improper Flow or Infusion	2	2
Failure to Eject	2	2
Loss of or Failure to Bond	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	341	341
No Known Impact Or Consequence To Patient	180	180
Hyperglycemia	146	146
No Clinical Signs, Symptoms or Conditions	140	140
Insufficient Information	36	36
Missed Dose	15	15
Hypoglycemia	15	15
Diabetic Ketoacidosis	11	11
Pain	10	10
Underdose	8	8
Needle Stick/Puncture	8	8
Aneurysm	7	7
No Information	6	6
Swelling	5	5
Reaction, Injection Site	4	4
Unspecified Infection	3	3
Bruise/Contusion	3	3
Loss of consciousness	3	3
No Code Available	3	3
Inflammation	3	3
Injury	3	3
Hemorrhage/Bleeding	2	2
Headache	2	2
Bacterial Infection	2	2
Anxiety	2	2
Dyspnea	2	2
No Patient Involvement	2	2
Erythema	2	2
Overdose	2	2
Scarring	2	2
Local Reaction	2	2
Itching Sensation	2	2
Nausea	2	2
Hypersensitivity/Allergic reaction	2	2
Alteration In Body Temperature	1	1
Fever	1	1
Irritation	1	1
Seroma	1	1
Weakness	1	1
Burning Sensation	1	1
Foreign Body In Patient	1	1
Blood Loss	1	1
Obstruction/Occlusion	1	1
Purulent Discharge	1	1
Abrasion	1	1
Chest Pain	1	1
Vomiting	1	1
Scar Tissue	1	1
Necrosis	1	1
Eye Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Becton Dickinson & Company	II	Nov-07-2011
2	International Medsurg Connection, Inc.	II	Aug-04-2017
3	Owen Mumford USA, Inc.	II	Nov-01-2019
4	Owen Mumford USA, Inc.	II	Apr-02-2015