TPLC - Total Product Life Cycle

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Device	device, intravascular catheter securement
Regulation Description	Intravascular catheter securement device.
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	200	205
Misconnection	70	71
Loss of or Failure to Bond	53	53
Adverse Event Without Identified Device or Use Problem	31	31
Defective Component	25	26
Difficult to Remove	19	19
Device Dislodged or Dislocated	10	10
Break	9	9
Improper or Incorrect Procedure or Method	9	9
Product Quality Problem	9	9
Difficult or Delayed Positioning	8	8
Contamination	7	7
Material Twisted/Bent	7	8
Unexpected Color	7	7
Fluid/Blood Leak	6	6
Misassembled	6	7
Contamination /Decontamination Problem	5	5
Patient Device Interaction Problem	5	5
Tear, Rip or Hole in Device Packaging	5	5
Material Deformation	5	5
Leak/Splash	4	4
Mechanical Problem	4	4
Appropriate Device Problem Term/Code Not Available	4	4
Component Missing	4	4
Material Separation	4	4
Component Misassembled	3	3
Unsealed Device Packaging	3	3
Disconnection	3	3
Difficult or Delayed Separation	2	2
Failure to Align	2	2
Obstruction of Flow	2	2
Free or Unrestricted Flow	2	2
Patient-Device Incompatibility	2	2
Nonstandard Device	2	2
Connection Problem	2	2
Separation Problem	2	2
Device Damaged Prior to Receipt by User	1	1
Adhesive Too Strong	1	1
Device Markings/Labelling Problem	1	1
Crack	1	1
Migration or Expulsion of Device	1	1
Biocompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	455	462
Insufficient Information	20	20
Hemorrhage/Blood Loss/Bleeding	10	10
Hypersensitivity/Allergic reaction	7	7
Skin Inflammation/ Irritation	6	6
Skin Tears	5	5
Blister	4	4
Skin Erosion	4	4
Ulcer	3	3
Unspecified Infection	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Inflammation	2	2
Abrasion	2	2
Tissue Breakdown	2	2
Itching Sensation	2	2
Local Reaction	2	2
Burn(s)	2	2
Erythema	2	2
Dyspnea	2	2
Pain	2	2
Decreased Appetite	1	1
Unintended Extubation	1	1
No Consequences Or Impact To Patient	1	1
Bacterial Infection	1	1
Caustic/Chemical Burns	1	1
Swelling/ Edema	1	1
Contact Dermatitis	1	1
Anxiety	1	1
Hypoglycemia	1	1
Renal Impairment	1	1
Unspecified Hepatic or Biliary Problem	1	1
Pressure Sore/Ulcer	1	1
Alteration in Body Temperature	1	1
Discomfort	1	1
Vasculitis	1	1
Chills	1	1
Fever	1	1
Unintended Loss of Vascular Access	1	1
Localized Skin Lesion	1	1
Chemical Exposure	1	1
Purulent Discharge	1	1
Aspiration/Inhalation	1	1
Diaphoresis	1	1
Fatigue	1	1