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	44	44
Misconnection	31	31
Adverse Event Without Identified Device or Use Problem	28	28
Defective Component	24	24
Break	13	13
Device Dislodged or Dislocated	11	11
Difficult to Remove	10	10
Detachment Of Device Component	9	9
Improper or Incorrect Procedure or Method	8	8
Patient-Device Incompatibility	8	8
Failure To Adhere Or Bond	8	8
Difficult or Delayed Positioning	8	8
Device Operates Differently Than Expected	7	7
Patient Device Interaction Problem	7	7
Mechanical Problem	7	7
Disconnection	6	6
Leak/Splash	6	6
Fluid/Blood Leak	6	6
Contamination	6	6
Material Separation	6	6
Material Twisted/Bent	5	5
Unsealed Device Packaging	4	4
Component Misassembled	4	4
Device Damaged Prior to Use	4	4
Device Slipped	3	3
Difficult to Open or Close	3	3
Nonstandard Device	3	3
Appropriate Term/Code Not Available	3	3
Contamination /Decontamination Problem	3	3
Misassembled	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Positioning Problem	3	3
Flaked	2	2
Material Integrity Problem	2	2
Peeled/Delaminated	2	2
Physical Property Issue	2	2
Crack	2	2
Sticking	2	2
Tear, Rip or Hole in Device Packaging	2	2
Device Contamination with Chemical or Other Material	2	2
Material Deformation	2	2
Difficult or Delayed Separation	2	2
Component Missing	2	2
Use of Device Problem	2	2
Separation Problem	2	2
Difficult To Position	1	1
Activation Failure	1	1
No Apparent Adverse Event	1	1
Torn Material	1	1

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	58	58
No Patient Involvement	14	14
Insufficient Information	13	13
No Consequences Or Impact To Patient	11	11
Hemorrhage/Bleeding	10	10
Hypersensitivity/Allergic reaction	8	8
Skin Tears	6	6
Skin Erosion	5	5
Pressure Sores	4	4
Rash	4	4
No Code Available	3	3
Ulcer	3	3
No Information	3	3
Inflammation	3	3
Reaction	3	3
Erythema	3	3
Tissue Breakdown	2	2
Dyspnea	2	2
Irritation	2	2
Injury	2	2
Chemical Exposure	2	2
Exsanguination	2	2
Skin Inflammation/ Irritation	2	2
Needle Stick/Puncture	1	1
Abrasion	1	1
Itching Sensation	1	1
Skin Inflammation	1	1
Local Reaction	1	1
Unspecified Hepatic or Biliary Problem	1	1
Renal Impairment	1	1
Pain	1	1
Aspiration/Inhalation	1	1
Hypoglycemia	1	1
Anxiety	1	1
Contact Dermatitis	1	1
Tissue Damage	1	1
Discharge	1	1
Skin Irritation	1	1
Phlebitis	1	1
Venipuncture	1	1
Unspecified Infection	1	1
Patient Problem/Medical Problem	1	1
Urticaria	1	1