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	66	66
Leak/Splash	27	27
Contamination /Decontamination Problem	21	21
Appropriate Term/Code Not Available	20	20
Suction Problem	17	17
Contamination	16	16
Fluid/Blood Leak	13	13
Break	13	13
Mechanical Problem	11	11
Detachment of Device or Device Component	8	8
Device Damaged Prior to Use	7	7
Device Markings/Labelling Problem	7	7
Physical Resistance/Sticking	6	6
Connection Problem	4	4
Suction Failure	4	4
Packaging Problem	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Defective Component	4	4
Defective Device	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Failure to Deliver	4	4
Tear, Rip or Hole in Device Packaging	3	3
Material Separation	3	3
Decrease in Suction	3	3
Insufficient Information	3	3
Crack	3	3
Output Problem	3	3
Therapeutic or Diagnostic Output Failure	2	2
Moisture Damage	2	2
Material Integrity Problem	2	2
Use of Device Problem	2	2
Infusion or Flow Problem	2	2
Material Split, Cut or Torn	2	2
Device Contaminated During Manufacture or Shipping	2	2
Failure to Clean Adequately	1	1
Unsealed Device Packaging	1	1
Patient Device Interaction Problem	1	1
Ejection Problem	1	1
Inability to Irrigate	1	1
Filling Problem	1	1
Partial Blockage	1	1
Labelling, Instructions for Use or Training Problem	1	1
Display Difficult to Read	1	1
Device Contamination with Body Fluid	1	1
Component Misassembled	1	1
Volume Accuracy Problem	1	1
Melted	1	1
Pressure Problem	1	1
Material Too Soft/Flexible	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	154	154
No Known Impact Or Consequence To Patient	59	59
No Patient Involvement	38	38
No Consequences Or Impact To Patient	20	20
Insufficient Information	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Unspecified Infection	3	3
Foreign Body In Patient	3	3
Fever	2	2
Exposure to Body Fluids	2	2
Pain	2	2
Fungal Infection	1	1
Muscle Weakness	1	1
Pelvic Inflammatory Disease	1	1
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