TPLC - Total Product Life Cycle

show TPLC since

Device	needle, aspiration and injection, disposable
Regulation Description	Manual surgical instrument for general use.
Product Code	GAA
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Defective Component	226	226
Device Contamination with Chemical or Other Material	185	186
Adverse Event Without Identified Device or Use Problem	83	83
Break	74	75
Contamination	66	67
Contamination /Decontamination Problem	36	36
Leak/Splash	33	34
Complete Blockage	20	20
Packaging Problem	20	20
Entrapment of Device	17	18
Detachment of Device or Device Component	9	10
Dull, Blunt	9	9
Connection Problem	8	8
Fracture	7	7
Fluid/Blood Leak	6	6
Device Markings/Labelling Problem	6	6
Tear, Rip or Hole in Device Packaging	5	5
Nonstandard Device	5	5
Material Twisted/Bent	5	5
Inaccurate Information	4	4
Material Puncture/Hole	4	4
Product Quality Problem	4	4
Material Discolored	4	4
Crack	4	4
Activation, Positioning or Separation Problem	4	4
Material Perforation	4	4
Material Deformation	4	4
Defective Device	3	5
Material Separation	3	4
Improper or Incorrect Procedure or Method	3	3
Delivered as Unsterile Product	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Illegible Information	3	3
Unclear Information	2	2
Loose or Intermittent Connection	2	2
Difficult to Remove	2	2
Component Missing	2	2
Degraded	2	2
Positioning Failure	2	2
Partial Blockage	2	2
Disconnection	2	2
Labelling, Instructions for Use or Training Problem	2	2
Application Network Problem	2	2
Contamination of Device Ingredient or Reagent	2	2
Device-Device Incompatibility	2	2
Device Contaminated During Manufacture or Shipping	2	7
Appropriate Term/Code Not Available	2	2
Migration	2	2
Material Split, Cut or Torn	1	1
Ejection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	681	689
Insufficient Information	78	79
Foreign Body In Patient	29	30
Endophthalmitis	26	26
Vitreous Floaters	20	20
No Consequences Or Impact To Patient	17	17
Pneumothorax	12	12
Eye Infections	6	6
Needle Stick/Puncture	5	5
Intraocular Infection	4	4
Phlebitis	4	4
Hemorrhage/Bleeding	4	4
Bronchial Hemorrhage	3	3
Inflammation	3	3
Cough	3	3
Unspecified Tissue Injury	3	3
Unspecified Infection	2	2
No Patient Involvement	2	2
Bradycardia	2	2
Abdominal Pain	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Macular Edema	1	1
Nausea	1	1
Bone Fracture(s)	1	1
Hemoptysis	1	1
Cardiac Arrest	1	1
Exposure to Body Fluids	1	1
Chest Pain	1	1
Pleural Effusion	1	1
Urinary Retention	1	1
Vomiting	1	1
Unspecified Eye / Vision Problem	1	1
Pain	1	3
Visual Impairment	1	1
Tachycardia	1	1
Low Blood Pressure/ Hypotension	1	1
Unintended Radiation Exposure	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aomori Olympus Co., Ltd.	II	Feb-05-2021
2	Hobbs Medical, Inc.	II	Oct-07-2022
3	INNOVATIVE TOMOGRAPHY PRODUCT GMBH	II	Jul-29-2021
4	M.D.L. S.r.l.	II	Sep-20-2021
5	North American Rescue LLC.	II	Sep-23-2021
6	Tytek Medical Inc	II	Sep-19-2023