TPLC - Total Product Life Cycle

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Device	device, intravascular catheter securement
Product Code	KMK
Regulation Number	880.5210
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	176	176
Loss of or Failure to Bond	78	78
Adverse Event Without Identified Device or Use Problem	35	35
Misconnection	31	31
Defective Component	24	24
Break	13	13
Difficult to Remove	12	12
Device Dislodged or Dislocated	11	11
Device Operates Differently Than Expected	11	11
Device Disinfection Or Sterilization Issue	11	11
Failure To Adhere Or Bond	11	11
Delivered as Unsterile Product	10	10
Detachment Of Device Component	9	9
Improper or Incorrect Procedure or Method	8	8
Patient-Device Incompatibility	8	8
Difficult or Delayed Positioning	8	8
Patient Device Interaction Problem	7	7
Material Separation	7	7
Disconnection	7	7
Leak/Splash	7	7
Mechanical Problem	7	7
Use of Device Problem	6	6
Fluid/Blood Leak	6	6
Contamination	6	6
Unsealed Device Packaging	6	6
Material Twisted/Bent	5	5
Difficult to Open or Close	5	5
Device Damaged Prior to Use	4	4
Component Misassembled	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Mechanics Altered	3	3
Device Slipped	3	3
Contamination /Decontamination Problem	3	3
Appropriate Term/Code Not Available	3	3
Nonstandard Device	3	3
Misassembled	3	3
Positioning Problem	3	3
Flaked	2	2
Failure to Disinfect	2	2
Separation Problem	2	2
Crack	2	2
Physical Property Issue	2	2
Peeled/Delaminated	2	2
Migration or Expulsion of Device	2	2
Difficult or Delayed Separation	2	2
Malposition of Device	2	2
Material Deformation	2	2
Connection Problem	2	2
Tear, Rip or Hole in Device Packaging	2	2
Material Integrity Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	327	327
No Known Impact Or Consequence To Patient	119	119
No Patient Involvement	14	14
Insufficient Information	13	13
No Consequences Or Impact To Patient	11	11
Hemorrhage/Bleeding	10	10
Hypersensitivity/Allergic reaction	9	9
Skin Tears	9	9
No Code Available	7	7
Skin Erosion	7	7
Erythema	5	5
Pressure Sores	4	4
Reaction	4	4
Rash	4	4
Ulcer	3	3
No Information	3	3
Inflammation	3	3
Tissue Breakdown	2	2
Dyspnea	2	2
Irritation	2	2
Injury	2	2
Confusion/ Disorientation	2	2
Chemical Exposure	2	2
Itching Sensation	2	2
Exsanguination	2	2
Skin Inflammation/ Irritation	2	2
Skin Irritation	2	2
Sepsis	2	2
Unspecified Infection	2	2
Abrasion	1	1
Foreign Body In Patient	1	1
Needle Stick/Puncture	1	1
Local Reaction	1	1
Edema	1	1
Swelling	1	1
Skin Inflammation	1	1
Aspiration/Inhalation	1	1
Unspecified Hepatic or Biliary Problem	1	1
Renal Impairment	1	1
Pain	1	1
Venipuncture	1	1
Hypoglycemia	1	1
Anxiety	1	1
Contact Dermatitis	1	1
Tissue Damage	1	1
Discharge	1	1
Phlebitis	1	1
Death	1	1
Patient Problem/Medical Problem	1	1
Urticaria	1	1