TPLC - Total Product Life Cycle

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Device	catheter, conduction, anesthetic
Regulation Description	Anesthesia conduction catheter.
Product Code	BSO
Regulation Number	868.5120
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	129	132
Material Twisted/Bent	100	100
Fluid/Blood Leak	76	76
Material Separation	66	66
Obstruction of Flow	47	47
No Flow	37	37
Difficult to Advance	20	20
Physical Resistance/Sticking	18	18
Material Too Soft/Flexible	18	18
Adverse Event Without Identified Device or Use Problem	16	16
Material Fragmentation	16	18
Disconnection	15	15
Leak/Splash	13	13
Detachment of Device or Device Component	13	14
Difficult to Remove	13	15
Material Split, Cut or Torn	11	11
Unsealed Device Packaging	9	9
Material Integrity Problem	8	8
Failure to Advance	7	7
Complete Blockage	7	7
Burst Container or Vessel	5	5
Activation, Positioning or Separation Problem	4	4
Material Puncture/Hole	4	4
Stretched	4	4
Defective Component	4	4
Defective Device	4	4
Fracture	3	3
Failure to Infuse	3	3
Material Deformation	3	3
Material Rupture	3	3
Device Dislodged or Dislocated	3	3
Unraveled Material	3	3
Premature Separation	3	3
Device Damaged Prior to Use	3	3
Incomplete or Inadequate Connection	3	3
Separation Problem	3	3
Contamination	2	2
Unintended Movement	2	2
Nonstandard Device	2	2
Use of Device Problem	2	2
Gas/Air Leak	2	2
Device Markings/Labelling Problem	2	2
Malposition of Device	2	2
Device Contamination with Body Fluid	2	2
Mechanical Problem	2	2
Pressure Problem	2	2
Dull, Blunt	2	2
Difficult to Open or Close	1	1
Corroded	1	1
Connection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	448	449
Foreign Body In Patient	109	111
Insufficient Information	70	73
Pain	20	20
Needle Stick/Puncture	15	15
Discomfort	8	8
Device Embedded In Tissue or Plaque	7	7
Unspecified Infection	6	6
Headache	5	5
Inadequate Pain Relief	4	4
Hematoma	3	3
Perforation	3	3
Bacterial Infection	3	3
Cerebrospinal Fluid Leakage	3	3
Swelling/ Edema	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Eye Pain	2	2
Embolism/Embolus	2	2
Hemorrhage/Bleeding	2	2
Spinal Column Injury	2	2
Paresthesia	2	2
Distress	1	1
Pulmonary Embolism	1	1
Low Oxygen Saturation	1	1
Respiratory Insufficiency	1	1
Convulsion/Seizure	1	1
Unspecified Tissue Injury	1	1
Perforation of Vessels	1	1
Tachycardia	1	1
Abscess	1	1
Dyspnea	1	1
Awareness during Anaesthesia	1	1
Fever	1	1
Foreign Body Reaction	1	1
Cellulitis	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Rupture	1	1
Purulent Discharge	1	1
Muscle Weakness	1	1
Fungal Infection	1	1
Sepsis	1	1
Decreased Sensitivity	1	1
Pneumothorax	1	1
Hypersensitivity/Allergic reaction	1	1
Neuropathy	1	1