TPLC - Total Product Life Cycle

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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	73	73
Migration or Expulsion of Device	50	50
Fluid/Blood Leak	49	49
Material Separation	38	38
Unraveled Material	31	31
Break	28	28
Defective Device	21	21
Detachment of Device or Device Component	19	19
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 Deformation	4	4
Material Twisted/Bent	4	4
Material Split, Cut or Torn	3	3
Fracture	3	3
Difficult to Open or Close	2	2
Gas/Air Leak	2	2
Use of Device Problem	2	2
Material Too Rigid or Stiff	2	2
Material Integrity Problem	2	2
Device-Device Incompatibility	2	2
Disconnection	2	2
Stretched	1	1
Difficult to Insert	1	1
Component Missing	1	1
Material Fragmentation	1	1
Patient Device Interaction Problem	1	1
Insufficient Information	1	1
Patient-Device Incompatibility	1	1
Device Damaged Prior to Use	1	1
No Apparent Adverse Event	1	1
Migration	1	1
Peeled/Delaminated	1	1
Device Dislodged or Dislocated	1	1
Entrapment of Device	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	173	173
Irritation	50	50
No Consequences Or Impact To Patient	44	44
Foreign Body In Patient	34	34
Insufficient Information	19	19
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
Low Oxygen Saturation	2	2
Inadequate Pain Relief	2	2
Perforation of Vessels	2	2
Laceration(s)	2	2
Seroma	2	2
Skin Inflammation/ Irritation	2	2
No Code Available	2	2
Failure of Implant	2	2
Unspecified Infection	2	2
Ventricular Fibrillation	1	1
Cardiac Arrest	1	1
Discomfort	1	1
Blister	1	1
No Information	1	1
Dyspnea	1	1
Respiratory Arrest	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
Convulsion/Seizure	1	1
Hypersensitivity/Allergic reaction	1	1
Skin Infection	1	1
High Blood Pressure/ Hypertension	1	1
Internal Organ Perforation	1	1
Air Embolism	1	1
Device Embedded In Tissue or Plaque	1	1