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	67	67
Leak/Splash	27	27
Contamination /Decontamination Problem	23	23
Appropriate Term/Code Not Available	20	20
Contamination	19	19
Suction Problem	18	18
Fluid/Blood Leak	14	14
Break	14	14
Mechanical Problem	11	11
Detachment of Device or Device Component	9	9
Device Markings/Labelling Problem	7	7
Device Damaged Prior to Use	7	7
Physical Resistance/Sticking	6	6
Insufficient Information	5	5
Packaging Problem	5	5
Suction Failure	4	4
Connection Problem	4	4
Defective Component	4	4
Defective Device	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Material Separation	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Failure to Deliver	4	4
Crack	3	3
Tear, Rip or Hole in Device Packaging	3	3
Output Problem	3	3
Decrease in Suction	3	3
Device Contaminated During Manufacture or Shipping	2	2
Material Split, Cut or Torn	2	3
Infusion or Flow Problem	2	2
Use of Device Problem	2	2
Moisture Damage	2	2
Therapeutic or Diagnostic Output Failure	2	2
Material Integrity Problem	2	2
Material Too Rigid or Stiff	1	1
Ejection Problem	1	1
Patient Device Interaction Problem	1	2
Failure to Clean Adequately	1	1
Partial Blockage	1	1
Labelling, Instructions for Use or Training Problem	1	1
Unsealed Device Packaging	1	1
Device Contamination with Body Fluid	1	1
Volume Accuracy Problem	1	1
Component Misassembled	1	1
Inability to Irrigate	1	1
Melted	1	1
Nonstandard Device	1	1
Pressure Problem	1	1
Filling Problem	1	1
Material Too Soft/Flexible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	167	168
No Known Impact Or Consequence To Patient	59	59
No Patient Involvement	38	38
No Consequences Or Impact To Patient	20	20
Insufficient Information	15	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Unspecified Infection	3	3
Foreign Body In Patient	3	3
Exposure to Body Fluids	3	3
Fever	2	2
Pain	2	2
Fungal Infection	1	1
Muscle Weakness	1	1
Pelvic Inflammatory Disease	1	2
Thrombosis/Thrombus	1	1
Discomfort	1	1
Unspecified Kidney or Urinary Problem	1	1
Bacterial Infection	1	1
Meningitis	1	1
Low Blood Pressure/ Hypotension	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