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	125	128
Fluid/Blood Leak	63	63
Material Separation	62	62
Material Twisted/Bent	58	58
Obstruction of Flow	47	47
No Flow	37	37
Difficult to Advance	20	20
Physical Resistance/Sticking	18	18
Material Fragmentation	16	18
Adverse Event Without Identified Device or Use Problem	16	16
Leak/Splash	13	13
Difficult to Remove	13	15
Disconnection	11	11
Detachment of Device or Device Component	11	12
Material Split, Cut or Torn	10	10
Material Too Soft/Flexible	10	10
Unsealed Device Packaging	9	9
Material Integrity Problem	8	8
Failure to Advance	7	7
Complete Blockage	6	6
Burst Container or Vessel	5	5
Activation, Positioning or Separation Problem	4	4
Defective Device	4	4
Stretched	4	4
Defective Component	4	4
Device Dislodged or Dislocated	3	3
Material Puncture/Hole	3	3
Fracture	3	3
Failure to Infuse	3	3
Incomplete or Inadequate Connection	3	3
Separation Problem	3	3
Premature Separation	3	3
Material Rupture	3	3
Unraveled Material	3	3
Device Damaged Prior to Use	3	3
Contamination	2	2
Device Markings/Labelling Problem	2	2
Malposition of Device	2	2
Gas/Air Leak	2	2
Material Deformation	2	2
Pressure Problem	2	2
Dull, Blunt	2	2
Unintended Movement	2	2
Mechanical Problem	2	2
Device Contamination with Body Fluid	2	2
Corroded	1	1
Crack	1	1
Positioning Failure	1	1
Entrapment of Device	1	1
Tear, Rip or Hole in Device Packaging	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	396	397
Foreign Body In Patient	106	108
Insufficient Information	59	62
Pain	18	18
Needle Stick/Puncture	15	15
Discomfort	7	7
Unspecified Infection	6	6
Device Embedded In Tissue or Plaque	6	6
Headache	4	4
Inadequate Pain Relief	3	3
Bacterial Infection	3	3
Swelling/ Edema	3	3
Perforation	3	3
Hemorrhage/Bleeding	2	2
Cerebrospinal Fluid Leakage	2	2
Paresthesia	2	2
Spinal Column Injury	2	2
Hematoma	2	2
Embolism/Embolus	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Cellulitis	1	1
Rupture	1	1
Foreign Body Reaction	1	1
Purulent Discharge	1	1
Fever	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Muscle Weakness	1	1
Dyspnea	1	1
Awareness during Anaesthesia	1	1
Abscess	1	1
Tachycardia	1	1
Fungal Infection	1	1
Unspecified Tissue Injury	1	1
Perforation of Vessels	1	1
Convulsion/Seizure	1	1
Sepsis	1	1
Pneumothorax	1	1
Respiratory Insufficiency	1	1
Decreased Sensitivity	1	1
Hypersensitivity/Allergic reaction	1	1
Neuropathy	1	1
Eye Pain	1	1
Low Oxygen Saturation	1	1
Pulmonary Embolism	1	1
Distress	1	1