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
1. K192349 Bactisure Wound Lavage
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	250	326
Battery Problem	187	187
Detachment of Device or Device Component	177	254
Inability to Irrigate	111	111
Failure to Power Up	83	83
Fluid/Blood Leak	77	122
Overheating of Device	76	76
Adverse Event Without Identified Device or Use Problem	71	71
Failure to Prime	58	58
Crack	53	53
Manufacturing, Packaging or Shipping Problem	52	52
Difficult to Insert	48	48
Explosion	48	48
Improper Flow or Infusion	47	47
Device Contaminated During Manufacture or Shipping	43	45
Connection Problem	43	43
Pressure Problem	40	40
Break	39	39
No Flow	35	35
Noise, Audible	30	30
Expulsion	29	29
Fracture	26	45
Power Problem	23	23
Appropriate Term/Code Not Available	23	23
Electrical /Electronic Property Problem	22	22
Material Rupture	22	22
Disconnection	22	22
Infusion or Flow Problem	21	21
Leak/Splash	21	21
Activation Problem	20	20
Corroded	20	20
Defective Device	20	20
Packaging Problem	20	20
Loose or Intermittent Connection	19	19
Smoking	17	17
Device Contamination with Chemical or Other Material	15	16
Mechanical Problem	15	15
Suction Problem	13	13
Activation, Positioning or Separation Problem	11	11
Melted	11	11
Defective Component	11	11
Vibration	10	10
Protective Measures Problem	10	10
Material Frayed	9	9
Material Deformation	9	9
Material Separation	9	9
Material Twisted/Bent	9	9
Contamination	9	9
Material Split, Cut or Torn	8	8
Decrease in Pressure	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1432	1626
No Consequences Or Impact To Patient	193	218
No Patient Involvement	78	104
No Known Impact Or Consequence To Patient	72	72
Insufficient Information	57	62
Post Operative Wound Infection	25	25
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
Unspecified Infection	3	3
Necrosis	3	3
Burn(s)	3	3
Laceration(s)	3	3
No Code Available	2	2
Aspiration/Inhalation	2	2
Dyspnea	2	2
Swelling/ Edema	2	2
Cerebrospinal Fluid Leakage	2	2
Wound Dehiscence	1	1
Stroke/CVA	1	1
Embolism/Embolus	1	1
Purulent Discharge	1	1
Blister	1	1
Reaction to Medicinal Component of Device	1	1
Erythema	1	1
Tissue Damage	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