TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ARMIS BIOPHARMA, INC.
	SUBSTANTIALLY EQUIVALENT	1
BD
	SUBSTANTIALLY EQUIVALENT	2
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1
BECTON, DICKINSON AND COMPANY (BD)
	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	452	452
Delivered as Unsterile Product	402	459
Suction Failure	278	278
Crack	185	185
Battery Problem	179	179
Detachment of Device or Device Component	148	228
Overheating of Device	116	116
Failure to Power Up	83	83
Adverse Event Without Identified Device or Use Problem	82	82
Explosion	69	69
Fluid/Blood Leak	59	91
Device Contaminated During Manufacture or Shipping	59	63
Manufacturing, Packaging or Shipping Problem	51	51
Pressure Problem	45	45
Mechanical Problem	44	44
Activation Problem	38	38
Powder Leak	34	34
Noise, Audible	34	34
Connection Problem	30	30
Break	30	30
Improper Flow or Infusion	29	29
Expulsion	27	27
Leak/Splash	26	26
Appropriate Term/Code Not Available	26	26
Fracture	25	44
No Flow	24	24
Failure to Prime	24	24
Difficult to Insert	22	22
Power Problem	22	22
Packaging Problem	22	22
Smoking	19	19
Electrical /Electronic Property Problem	18	18
Corroded	16	16
Material Rupture	14	14
Suction Problem	14	14
Defective Device	14	14
Material Deformation	13	13
Infusion or Flow Problem	12	12
Loose or Intermittent Connection	12	12
Melted	11	11
Unsealed Device Packaging	11	11
Material Twisted/Bent	10	10
Material Separation	10	10
Contamination	10	10
Patient Device Interaction Problem	9	9
Tear, Rip or Hole in Device Packaging	8	8
Contamination /Decontamination Problem	8	8
Material Frayed	8	8
Material Integrity Problem	8	8
Defective Component	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2196	2389
Insufficient Information	85	91
Post Operative Wound Infection	26	26
Hypersensitivity/Allergic reaction	14	14
Impaired Healing	13	13
Burning Sensation	9	9
No Consequences Or Impact To Patient	9	9
Rash	8	8
Foreign Body In Patient	7	8
Skin Inflammation/ Irritation	5	5
Unspecified Infection	4	4
Itching Sensation	4	4
Reaction to Medicinal Component of Device	4	4
Burn(s)	4	4
Laceration(s)	4	4
Necrosis	3	3
Hematoma	3	3
Blister	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
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
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