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
Material Twisted/Bent	121	121
Break	113	113
Fluid/Blood Leak	77	77
Material Separation	63	63
Obstruction of Flow	47	47
No Flow	37	37
Difficult to Advance	20	20
Adverse Event Without Identified Device or Use Problem	18	18
Material Too Soft/Flexible	18	18
Physical Resistance/Sticking	17	17
Material Fragmentation	15	17
Disconnection	13	13
Leak/Splash	12	12
Material Split, Cut or Torn	11	11
Difficult to Remove	11	11
Detachment of Device or Device Component	10	11
Unsealed Device Packaging	9	9
Complete Blockage	7	7
Failure to Advance	7	7
Material Integrity Problem	7	7
Burst Container or Vessel	5	5
Activation, Positioning or Separation Problem	4	4
Defective Component	4	4
Material Puncture/Hole	4	4
Premature Separation	3	3
Separation Problem	3	3
Incomplete or Inadequate Connection	3	3
Fracture	3	3
Failure to Infuse	3	3
Device Dislodged or Dislocated	3	3
Material Deformation	3	3
Stretched	3	3
Material Rupture	3	3
Malposition of Device	2	2
Defective Device	2	2
Dull, Blunt	2	2
Device Contamination with Body Fluid	2	2
Device Damaged Prior to Use	2	2
Use of Device Problem	2	2
Unraveled Material	2	2
Nonstandard Device	2	2
Mechanical Problem	2	2
Unintended Movement	2	2
Pressure Problem	2	2
Gas/Air Leak	2	2
Device Markings/Labelling Problem	2	2
Delivered as Unsterile Product	1	1
Device Emits Odor	1	1
Off-Label Use	1	1
Pumping Stopped	1	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	467	468
Foreign Body In Patient	109	111
Insufficient Information	74	77
Pain	21	21
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
Cerebrospinal Fluid Leakage	3	3
Hematoma	3	3
Perforation	3	3
Bacterial Infection	3	3
Swelling/ Edema	3	3
Eye Pain	2	2
Purulent Discharge	2	2
Inflammation	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Paresthesia	2	2
Medical device site infection	2	2
Embolism/Embolus	2	2
Hemorrhage/Blood Loss/Bleeding	2	2
Spinal Column Injury	2	2
Rupture	1	1
Unspecified Tissue Injury	1	1
Hypersensitivity/Allergic reaction	1	1
Tachycardia	1	1
Pneumothorax	1	1
Pulmonary Embolism	1	1
Respiratory Insufficiency	1	1
Perforation of Vessels	1	1
Fungal Infection	1	1
Cellulitis	1	1
Low Oxygen Saturation	1	1
Muscle Weakness/Atrophy	1	1
Distress	1	1
Convulsion/Seizure	1	1
Awareness during Anaesthesia	1	1
Sepsis	1	1
Hyporesponsive to stimuli	1	1
Foreign Body Reaction	1	1
Dyspnea	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Paraplegia	1	1
Fever	1	1
Neuropathy	1	1
Abscess	1	1