TPLC - Total Product Life Cycle

show TPLC since

Device	syringe, irrigating (non dental)
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	99	99
Contamination /Decontamination Problem	33	33
Leak/Splash	32	32
Break	20	20
Appropriate Term/Code Not Available	19	19
Suction Problem	17	17
Contamination	16	16
Fluid/Blood Leak	14	14
Device Markings/Labelling Problem	12	12
Mechanical Problem	11	11
Physical Resistance/Sticking	9	9
Device Damaged Prior to Use	8	8
Detachment of Device or Device Component	8	8
Manufacturing, Packaging or Shipping Problem	5	5
Suction Failure	5	5
Decrease in Suction	5	5
Packaging Problem	4	4
Connection Problem	4	4
Defective Device	4	4
Defective Component	4	4
Volume Accuracy Problem	4	4
Failure to Deliver	4	4
Output Problem	3	3
Material Separation	3	3
Tear, Rip or Hole in Device Packaging	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Particulates	2	2
Component Missing	2	2
Use of Device Problem	2	2
Infusion or Flow Problem	2	2
Moisture Damage	2	2
Material Puncture/Hole	2	2
Crack	2	2
Material Split, Cut or Torn	2	2
Device Contaminated During Manufacture or Shipping	2	2
Therapeutic or Diagnostic Output Failure	2	2
Structural Problem	1	1
Material Fragmentation	1	1
Component Misassembled	1	1
Patient Device Interaction Problem	1	1
Ejection Problem	1	1
Partial Blockage	1	1
Labelling, Instructions for Use or Training Problem	1	1
Protective Measures Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Biocompatibility	1	1
Failure to Seal	1	1
Filling Problem	1	1
Insufficient Information	1	1
Inability to Irrigate	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	138	138
No Known Impact Or Consequence To Patient	117	117
No Patient Involvement	67	67
No Consequences Or Impact To Patient	34	34
Insufficient Information	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Foreign Body In Patient	6	6
No Information	3	3
Exposure to Body Fluids	3	3
Pain	3	3
Unspecified Infection	1	1
Nausea	1	1
Fungal Infection	1	1
No Code Available	1	1
Aspiration/Inhalation	1	1
Muscle Weakness	1	1
Abrasion	1	1
Pelvic Inflammatory Disease	1	1
Thrombosis/Thrombus	1	1
Discomfort	1	1
Numbness	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	Feb-10-2023