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	72	72
Fluid/Blood Leak	39	39
Material Separation	30	30
Unraveled Material	25	25
Break	24	24
Defective Device	21	21
Detachment of Device or Device Component	18	18
Unsealed Device Packaging	11	11
Adverse Event Without Identified Device or Use Problem	10	10
Crack	8	8
Difficult to Remove	8	8
Degraded	6	6
Device Contaminated During Manufacture or Shipping	5	5
Difficult to Advance	5	5
Nonstandard Device	4	4
Material Split, Cut or Torn	3	3
Physical Resistance/Sticking	3	3
Material Deformation	3	3
Material Integrity Problem	2	2
Entrapment of Device	2	2
Difficult to Open or Close	2	2
Material Too Rigid or Stiff	2	3
Gas/Air Leak	2	2
Labelling, Instructions for Use or Training Problem	2	2
Device-Device Incompatibility	2	2
Device Endoleak	1	1
Device Damaged Prior to Use	1	1
Contamination	1	1
Material Fragmentation	1	1
Deformation Due to Compressive Stress	1	1
Stretched	1	1
Component Missing	1	1
Patient Device Interaction Problem	1	1
Loss of or Failure to Bond	1	1
Loose or Intermittent Connection	1	1
No Apparent Adverse Event	1	1
Disconnection	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	195	195
Foreign Body In Patient	35	35
Insufficient Information	21	21
Awareness during Anaesthesia	7	7
No Consequences Or Impact To Patient	6	6
Low Blood Pressure/ Hypotension	6	6
Pain	4	4
Hemorrhage/Blood Loss/Bleeding	4	4
Tachycardia	3	3
Unspecified Infection	2	3
Failure of Implant	2	2
Low Oxygen Saturation	2	2
Perforation of Vessels	2	2
Distress	2	2
Seroma	2	3
Discomfort	2	2
Skin Inflammation/ Irritation	2	2
Inadequate Pain Relief	2	2
Convulsion/Seizure	1	1
High Blood Pressure/ Hypertension	1	1
No Patient Involvement	1	1
Dyspnea	1	1
Abnormal Blood Gases	1	1
Ventricular Fibrillation	1	1
Cough	1	1
Great Vessel Perforation	1	1
Internal Organ Perforation	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Hyperventilation	1	1
Hypersensitivity/Allergic reaction	1	1
Respiratory Arrest	1	1
Cardiac Arrest	1	1
Coma	1	1
Swelling/ Edema	1	1
Skin Infection	1	1
Blister	1	1
Laceration(s)	1	1
Device Embedded In Tissue or Plaque	1	1