TPLC - Total Product Life Cycle

show TPLC since

Device	accessories, catheter
Regulation Description	Introduction/drainage catheter and accessories.
Product Code	KGZ
Regulation Number	878.4200
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	69	69
Migration or Expulsion of Device	50	50
Fluid/Blood Leak	47	47
Material Separation	34	34
Unraveled Material	28	28
Break	26	26
Defective Device	20	20
Detachment of Device or Device Component	18	18
Loss of or Failure to Bond	16	16
Unsealed Device Packaging	10	10
Difficult to Remove	10	10
Crack	9	9
Adverse Event Without Identified Device or Use Problem	8	8
Degraded	6	6
Difficult to Advance	5	5
Device Contaminated During Manufacture or Shipping	4	4
Physical Resistance/Sticking	4	4
Material Twisted/Bent	4	4
Material Deformation	4	4
Material Split, Cut or Torn	3	3
Fracture	3	3
Disconnection	2	2
Device-Device Incompatibility	2	2
Material Integrity Problem	2	2
Material Too Rigid or Stiff	2	2
Use of Device Problem	2	2
Gas/Air Leak	2	2
Difficult to Open or Close	2	2
Entrapment of Device	1	1
Peeled/Delaminated	1	1
Device Damaged Prior to Use	1	1
Patient-Device Incompatibility	1	1
Insufficient Information	1	1
Patient Device Interaction Problem	1	1
Difficult to Insert	1	1
Stretched	1	1
Component Missing	1	1
No Apparent Adverse Event	1	1
Migration	1	1
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	162	162
Irritation	50	50
No Consequences Or Impact To Patient	44	44
Foreign Body In Patient	30	30
Insufficient Information	18	18
No Known Impact Or Consequence To Patient	12	12
Awareness during Anaesthesia	7	7
Low Blood Pressure/ Hypotension	6	6
No Patient Involvement	5	5
Hemorrhage/Bleeding	4	4
Pain	3	3
Unspecified Infection	2	2
Failure of Implant	2	2
No Code Available	2	2
Skin Inflammation/ Irritation	2	2
Seroma	2	2
Laceration(s)	2	2
Perforation of Vessels	2	2
Inadequate Pain Relief	2	2
Low Oxygen Saturation	2	2
Air Embolism	1	1
High Blood Pressure/ Hypertension	1	1
Skin Infection	1	1
Hypersensitivity/Allergic reaction	1	1
Respiratory Arrest	1	1
No Information	1	1
Blister	1	1
Cardiac Arrest	1	1
Ventricular Fibrillation	1	1
Discomfort	1	1
Dyspnea	1	1
Coma	1	1
Tachycardia	1	1
Cough	1	1
Swelling/ Edema	1	1
Hyperventilation	1	1
Great Vessel Perforation	1	1
Pseudoaneurysm	1	1
Internal Organ Perforation	1	1
Device Embedded In Tissue or Plaque	1	1