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
Decrease in Suction	5	5
Suction Failure	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Defective Device	4	4
Defective Component	4	4
Packaging Problem	4	4
Failure to Deliver	4	4
Volume Accuracy Problem	4	4
Connection Problem	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Material Separation	3	3
Tear, Rip or Hole in Device Packaging	3	3
Output Problem	3	3
Infusion or Flow Problem	2	2
Particulates	2	2
Component Missing	2	2
Use of Device Problem	2	2
Moisture Damage	2	2
Therapeutic or Diagnostic Output Failure	2	2
Material Puncture/Hole	2	2
Crack	2	2
Device Contaminated During Manufacture or Shipping	2	2
Material Split, Cut or Torn	2	2
Material Fragmentation	1	1
Melted	1	1
Material Too Soft/Flexible	1	1
Ejection Problem	1	1
Patient Device Interaction Problem	1	1
Incomplete or Missing Packaging	1	1
Device Contamination with Body Fluid	1	1
Unsealed Device Packaging	1	1
Material Integrity Problem	1	1
Delivered as Unsterile Product	1	1
Failure to Clean Adequately	1	1
Misassembled	1	1
Material Deformation	1	1
Component Misassembled	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
No Code Available	1	1
Fungal Infection	1	1
Aspiration/Inhalation	1	1
Muscle Weakness	1	1
Abrasion	1	1
Pelvic Inflammatory Disease	1	1
Thrombosis/Thrombus	1	1
Numbness	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	Feb-10-2023