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
Detachment of Device or Device Component	8	8
Device Damaged Prior to Use	8	8
Manufacturing, Packaging or Shipping Problem	5	5
Suction Failure	5	5
Decrease in Suction	5	5
Connection Problem	4	4
Defective Component	4	4
Volume Accuracy Problem	4	4
Defective Device	4	4
Packaging Problem	4	4
Failure to Deliver	4	4
Tear, Rip or Hole in Device Packaging	3	3
Material Separation	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Output Problem	3	3
Moisture Damage	2	2
Particulates	2	2
Material Puncture/Hole	2	2
Infusion or Flow Problem	2	2
Crack	2	2
Therapeutic or Diagnostic Output Failure	2	2
Device Contaminated During Manufacture or Shipping	2	2
Material Split, Cut or Torn	2	2
Use of Device Problem	2	2
Component Missing	2	2
Ejection Problem	1	1
Patient Device Interaction Problem	1	1
Material Fragmentation	1	1
Filling Problem	1	1
Structural Problem	1	1
Inability to Irrigate	1	1
Misassembled	1	1
Material Deformation	1	1
Delivered as Unsterile Product	1	1
Display Difficult to Read	1	1
Insufficient Information	1	1
Device Contamination with Body Fluid	1	1
Incomplete or Missing Packaging	1	1
Failure to Clean Adequately	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