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	3
NEXT SCIENCE, LLC
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPHOR, LLC
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Delivered as Unsterile Product	293	369
Battery Problem	187	187
Detachment of Device or Device Component	178	255
Inability to Irrigate	127	127
Overheating of Device	94	94
Failure to Power Up	89	89
Fluid/Blood Leak	77	122
Adverse Event Without Identified Device or Use Problem	74	74
Crack	58	58
Failure to Prime	58	58
Explosion	58	58
Manufacturing, Packaging or Shipping Problem	53	53
Improper Flow or Infusion	49	49
Device Contaminated During Manufacture or Shipping	49	53
Difficult to Insert	48	48
Pressure Problem	46	46
Connection Problem	43	43
Break	39	39
No Flow	35	35
Noise, Audible	33	33
Expulsion	30	30
Activation Problem	28	28
Fracture	27	46
Appropriate Term/Code Not Available	26	26
Power Problem	25	25
Material Rupture	23	23
Leak/Splash	23	23
Corroded	22	22
Disconnection	22	22
Electrical /Electronic Property Problem	22	22
Infusion or Flow Problem	21	21
Packaging Problem	21	21
Defective Device	20	20
Loose or Intermittent Connection	19	19
Mechanical Problem	19	19
Smoking	17	17
Device Contamination with Chemical or Other Material	15	16
Suction Problem	13	13
Material Deformation	12	12
Activation, Positioning or Separation Problem	11	11
Melted	11	11
Defective Component	11	11
Protective Measures Problem	10	10
Vibration	10	10
Contamination	9	9
Material Frayed	9	9
Material Integrity Problem	9	9
Material Twisted/Bent	9	9
Material Separation	9	9
Decrease in Pressure	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1558	1754
No Consequences Or Impact To Patient	193	218
No Patient Involvement	78	104
No Known Impact Or Consequence To Patient	72	72
Insufficient Information	67	72
Post Operative Wound Infection	26	26
Impaired Healing	13	13
Hypersensitivity/Allergic reaction	12	12
Foreign Body In Patient	10	11
Burning Sensation	9	9
No Information	6	6
Rash	6	6
Injury	6	6
Burn(s)	3	3
Hematoma	3	3
Unspecified Infection	3	3
Laceration(s)	3	3
Necrosis	3	3
Aspiration/Inhalation	2	2
Cerebrospinal Fluid Leakage	2	2
Purulent Discharge	2	2
Dyspnea	2	2
Reaction to Medicinal Component of Device	2	2
Swelling/ Edema	2	2
No Code Available	2	2
Wound Dehiscence	1	1
Myocardial Contusion	1	1
Stroke/CVA	1	1
Erythema	1	1
Hemorrhage/Bleeding	1	1
Blister	1	1
Skin Inflammation/ Irritation	1	1
Embolism/Embolus	1	1
Itching Sensation	1	1
Renal Failure	1	1
Shock	1	1
Tissue Damage	1	1
Low Cardiac Output	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