TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ARMIS BIOPHARMA, INC.
	SUBSTANTIALLY EQUIVALENT	1
BD
	SUBSTANTIALLY EQUIVALENT	1
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1
ERBE ELEKTROMEDIZIN GMBH
	SUBSTANTIALLY EQUIVALENT	1
INOPRO, INC.
	SUBSTANTIALLY EQUIVALENT	1
IRRIMAX CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
SMITH & NEPHEW MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Inability to Irrigate	432	432
Delivered as Unsterile Product	350	407
Suction Failure	271	271
Battery Problem	175	175
Crack	159	159
Detachment of Device or Device Component	138	216
Overheating of Device	105	105
Adverse Event Without Identified Device or Use Problem	80	80
Failure to Power Up	77	77
Explosion	65	65
Fluid/Blood Leak	59	91
Device Contaminated During Manufacture or Shipping	54	58
Manufacturing, Packaging or Shipping Problem	51	51
Pressure Problem	44	44
Activation Problem	33	33
Noise, Audible	30	30
Connection Problem	30	30
Break	30	30
Improper Flow or Infusion	29	29
Powder Leak	27	27
Expulsion	27	27
Appropriate Term/Code Not Available	26	26
Fracture	25	44
No Flow	23	23
Mechanical Problem	23	23
Failure to Prime	23	23
Difficult to Insert	22	22
Leak/Splash	21	21
Packaging Problem	21	21
Power Problem	20	20
Electrical /Electronic Property Problem	18	18
Smoking	16	16
Suction Problem	14	14
Defective Device	13	13
Material Rupture	13	13
Material Deformation	13	13
Corroded	13	13
Infusion or Flow Problem	12	12
Melted	11	11
Loose or Intermittent Connection	11	11
Material Separation	10	10
Unsealed Device Packaging	9	9
Material Twisted/Bent	9	9
Contamination	9	9
Tear, Rip or Hole in Device Packaging	8	8
Defective Component	8	8
Material Integrity Problem	8	8
Contamination /Decontamination Problem	8	8
Patient Device Interaction Problem	8	8
Material Frayed	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2013	2204
Insufficient Information	73	79
Post Operative Wound Infection	26	26
Impaired Healing	13	13
Hypersensitivity/Allergic reaction	13	13
Burning Sensation	9	9
No Consequences Or Impact To Patient	9	9
Rash	7	7
Foreign Body In Patient	6	7
Unspecified Infection	4	4
Skin Inflammation/ Irritation	4	4
Reaction to Medicinal Component of Device	4	4
Burn(s)	4	4
Laceration(s)	4	4
Necrosis	3	3
Hematoma	3	3
Erythema	3	3
Hemorrhage/Bleeding	3	3
Skin Infection	2	2
Aspiration/Inhalation	2	2
Embolism/Embolus	2	2
Purulent Discharge	2	2
Itching Sensation	2	2
Dyspnea	2	2
Swelling/ Edema	2	2
Cerebrospinal Fluid Leakage	2	2
Wound Dehiscence	1	1
Stroke/CVA	1	1
Sepsis	1	1
Low Cardiac Output	1	1
Blister	1	1
No Known Impact Or Consequence To Patient	1	1
Ventricular Fibrillation	1	1
Myocardial Contusion	1	1
No Patient Involvement	1	1
Renal Failure	1	1
Shock	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Mckesson Medical-Surgical Inc. Corporate Office	III	Sep-26-2022
2	Medtronic Perfusion Systems	II	May-10-2024