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	68	68
Fluid/Blood Leak	36	36
Material Separation	30	30
Break	28	28
Unraveled Material	23	23
Defective Device	21	21
Detachment of Device or Device Component	15	15
Unsealed Device Packaging	10	10
Difficult to Remove	10	10
Crack	8	8
Adverse Event Without Identified Device or Use Problem	8	8
Degraded	6	6
Device Contaminated During Manufacture or Shipping	4	4
Physical Resistance/Sticking	4	4
Difficult to Advance	4	4
Material Deformation	4	4
Material Split, Cut or Torn	3	3
Disconnection	2	2
Device-Device Incompatibility	2	2
Entrapment of Device	2	2
Material Integrity Problem	2	2
Material Too Rigid or Stiff	2	3
Gas/Air Leak	2	2
Difficult to Open or Close	2	2
Peeled/Delaminated	1	1
Device Damaged Prior to Use	1	1
Patient-Device Incompatibility	1	1
Patient Device Interaction Problem	1	1
Material Fragmentation	1	1
Difficult to Insert	1	1
Stretched	1	1
Use of Device Problem	1	1
Component Missing	1	1
Material Twisted/Bent	1	1
No Apparent Adverse Event	1	1
Migration	1	1
Fracture	1	1
Device Dislodged or Dislocated	1	1
Loose or Intermittent Connection	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	181	181
Foreign Body In Patient	31	31
Insufficient Information	20	20
Awareness during Anaesthesia	7	7
No Consequences Or Impact To Patient	6	6
Low Blood Pressure/ Hypotension	5	5
Pain	3	3
Hemorrhage/Bleeding	3	3
Unspecified Infection	2	3
Failure of Implant	2	2
Skin Inflammation/ Irritation	2	2
Seroma	2	3
Perforation of Vessels	2	2
Tachycardia	2	2
Inadequate Pain Relief	2	2
Low Oxygen Saturation	2	2
High Blood Pressure/ Hypertension	1	1
Skin Infection	1	1
Hypersensitivity/Allergic reaction	1	1
Respiratory Arrest	1	1
Abnormal Blood Gases	1	1
Blister	1	1
Cardiac Arrest	1	1
Ventricular Fibrillation	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
No Patient Involvement	1	1
Discomfort	1	1
Laceration(s)	1	1
Dyspnea	1	1
Coma	1	1
Cough	1	1
Swelling/ Edema	1	1
Great Vessel Perforation	1	1
Hyperventilation	1	1
Convulsion/Seizure	1	1
Internal Organ Perforation	1	1
Device Embedded In Tissue or Plaque	1	1
Distress	1	1