TPLC - Total Product Life Cycle

• Device: syringe, irrigating (non dental)
• Regulation Description: Irrigating syringe.
• Product Code: KYZ
• Regulation Number: 880.6960
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
SAFKAN, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2016	8	8
2017	52	52
2018	76	76
2019	69	69
2020	88	88
2021	17	17

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Contamination with Chemical or Other Material	155	155
Contamination /Decontamination Problem	35	35
Break	27	27
Leak/Splash	22	22
Device Markings/Labelling Problem	13	13
Fluid Leak	13	13
Contamination	11	11
Suction Problem	9	9
Detachment Of Device Component	7	7
Device Damaged Prior to Use	7	7
Physical Resistance/Sticking	6	6
Material Fragmentation	6	6
Expiration Date Error	6	6
Suction Failure	5	5
Decrease in Suction	5	5
Material Discolored	4	4
Loose or Intermittent Connection	4	4
Defective Component	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Volume Accuracy Problem	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Delivered as Unsterile Product	3	3
Device Disinfection Or Sterilization Issue	3	3
Failure to Deliver	3	3
Defective Device	3	3
Output Problem	3	3
Packaging Problem	2	2
Use of Device Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Appropriate Term/Code Not Available	2	2
Detachment of Device or Device Component	2	2
Component Missing	2	2
Mechanical Problem	2	2
Unsealed Device Packaging	2	2
Particulates	2	2
Material Puncture/Hole	2	2
Device Inoperable	2	2
Fungus in Device Environment	2	2
Misassembled	2	2
Material Deformation	2	2
Device Contaminated During Manufacture or Shipping	2	2
Tear, Rip or Hole in Device Packaging	2	2
Fitting Problem	2	2
Device Contamination With Biological Material	2	2
Contamination of Device Ingredient or Reagent	1	1
Biocompatibility	1	1
Improper or Incorrect Procedure or Method	1	1
Difficult to Advance	1	1
Material Integrity Problem	1	1
Component Misassembled	1	1
Component Falling	1	1
Disconnection	1	1
Entrapment of Device	1	1
Flaked	1	1
Inability to Irrigate	1	1
Device Contamination with Body Fluid	1	1
Unstable	1	1
Occlusion Within Device	1	1
Sticking	1	1
Device Fell	1	1
Device Slipped	1	1
Out-Of-Box Failure	1	1
Incomplete or Missing Packaging	1	1
Gel Leak	1	1
Labelling, Instructions for Use or Training Problem	1	1
Burst Container or Vessel	1	1
Device Reprocessing Problem	1	1
Filling Problem	1	1
Device Operates Differently Than Expected	1	1
Device Packaging Compromised	1	1
Structural Problem	1	1
Physical Resistance	1	1
Application Program Problem: Medication Error	1	1
Ejection Problem	1	1
Protective Measures Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	202	202
No Patient Involvement	100	100
No Consequences Or Impact To Patient	54	54
No Information	21	21
No Clinical Signs, Symptoms or Conditions	11	11
Foreign Body In Patient	6	6
Pain	3	3
Insufficient Information	3	3
Burn(s)	3	3
Skin Tears	2	2
Vitreous Floaters	1	1
Abrasion	1	1
Aspiration/Inhalation	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Numbness	1	1
Urinary Tract Infection	1	1
Visual Impairment	1	1
Discomfort	1	1
Complaint, Ill-Defined	1	1
Bacterial Infection	1	1
Exposure to Body Fluids	1	1
Hemorrhage/Bleeding	1	1
Unspecified Infection	1	1
Nausea	1	1
No Code Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Mar-01-2018
2	C.R. Bard, Inc.	II	Dec-12-2016
3	C.R. Bard, Inc.	III	Feb-16-2016
4	Cook Inc.	II	Mar-26-2018
5	Customed, Inc	II	Apr-14-2016
6	Shippert Medical Technologies	II	Aug-22-2017