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	41	41
Misconnection	31	31
Defective Component	23	23
Adverse Event Without Identified Device or Use Problem	21	21
Difficult to Remove	10	10
Break	9	9
Improper or Incorrect Procedure or Method	8	8
Difficult or Delayed Positioning	8	8
Device Dislodged or Dislocated	8	8
Leak/Splash	6	6
Contamination	6	6
Disconnection	5	5
Material Twisted/Bent	5	5
Fluid/Blood Leak	5	5
Patient Device Interaction Problem	5	5
Component Misassembled	4	4
Material Separation	4	4
Mechanical Problem	4	4
Patient-Device Incompatibility	4	4
Misassembled	3	3
Contamination /Decontamination Problem	3	3
Nonstandard Device	3	3
Flaked	2	2
Difficult or Delayed Separation	2	2
Material Deformation	2	2
Component Missing	2	2
Crack	2	2
Appropriate Term/Code Not Available	2	2
Tear, Rip or Hole in Device Packaging	2	2
Unsealed Device Packaging	2	2
Separation Problem	2	2
Device Damaged Prior to Use	1	1
Migration or Expulsion of Device	1	1
Difficult to Open or Close	1	1
Connection Problem	1	1
Inadequate Instructions for Healthcare Professional	1	1
Adhesive Too Strong	1	1
Fail-Safe Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Failure to Align	1	1
Activation Failure	1	1
Free or Unrestricted Flow	1	1
No Apparent Adverse Event	1	1
Positioning Problem	1	1
Packaging Problem	1	1
Activation, Positioning or Separation Problem	1	1
Material Split, Cut or Torn	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	327	327
Insufficient Information	13	13
No Known Impact Or Consequence To Patient	12	12
Hemorrhage/Bleeding	10	10
No Patient Involvement	8	8
Hypersensitivity/Allergic reaction	5	5
Skin Erosion	5	5
Skin Tears	5	5
Ulcer	3	3
Skin Inflammation/ Irritation	2	2
Exsanguination	2	2
Inflammation	2	2
Chemical Exposure	2	2
Erythema	2	2
Dyspnea	2	2
No Consequences Or Impact To Patient	2	2
Tissue Breakdown	2	2
Unspecified Infection	1	1
Skin Irritation	1	1
Aspiration/Inhalation	1	1
Abrasion	1	1
Itching Sensation	1	1
Pain	1	1
Unspecified Hepatic or Biliary Problem	1	1
Renal Impairment	1	1
Hypoglycemia	1	1
Reaction	1	1
Anxiety	1	1
Contact Dermatitis	1	1
Phlebitis	1	1
Discharge	1	1
Pressure Sores	1	1