TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Contamination with Chemical or Other Material	34	34
Contamination	21	21
Appropriate Device Problem Term/Code Not Available	20	20
Leak/Splash	17	17
Break	13	13
Mechanical Problem	11	11
Suction Problem	11	11
Detachment of Device or Device Component	10	10
Fluid/Blood Leak	5	5
Device Markings/Labelling Problem	5	5
Contamination /Decontamination Problem	5	5
Insufficient Device Problem Information	5	5
Packaging Problem	5	5
Physical Resistance/Sticking	4	4
Connection Problem	4	4
Material Separation	4	4
Crack	3	3
Failure to Deliver	3	3
Infusion or Flow Problem	3	3
Material Split, Cut or Torn	2	3
Material Integrity Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Moisture Damage	2	2
Tear, Rip or Hole in Device Packaging	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Failure to Seal	1	1
Loose or Intermittent Connection	1	1
Material Too Soft/Flexible	1	1
Nonstandard Device	1	1
Melted	1	1
Partial Blockage	1	1
Decrease in Suction	1	1
Use of Device Problem	1	1
Material Too Rigid or Stiff	1	1
Patient Device Interaction Problem	1	2
Failure to Clean Adequately	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Defective Device	1	1
Device Damaged Prior to Use	1	1
Display Difficult to Read	1	1
Pressure Problem	1	1
Device Contaminated During Manufacture or Shipping	1	1
Disconnection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	167	168
Insufficient Information	15	15
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	8	8
No Patient Involvement	5	5
Foreign Body In Patient	4	4
No Consequences Or Impact To Patient	4	4
Exposure to Body Fluids	3	3
Unspecified Infection	3	3
Fever	2	2
Pain	2	2
Pelvic Inflammatory Disease	1	2
Meningitis	1	1
Fungal Infection	1	1
Low Blood Pressure/ Hypotension	1	1
Muscle Weakness/Atrophy	1	1
Thrombosis/Thrombus	1	1
Unspecified Kidney or Urinary Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cardinal Health 200, LLC	I	Feb-16-2024
2	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-30-2024
3	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-10-2023