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	123	126
Fluid/Blood Leak	62	62
Material Separation	61	61
Material Twisted/Bent	54	54
Obstruction of Flow	47	47
No Flow	37	37
Difficult to Advance	20	20
Physical Resistance/Sticking	17	17
Adverse Event Without Identified Device or Use Problem	16	16
Material Fragmentation	15	17
Leak/Splash	13	13
Difficult to Remove	12	14
Disconnection	11	11
Detachment of Device or Device Component	11	12
Material Split, Cut or Torn	10	10
Unsealed Device Packaging	9	9
Material Integrity Problem	8	8
Failure to Advance	7	7
Material Too Soft/Flexible	6	6
Complete Blockage	6	6
Burst Container or Vessel	5	5
Activation, Positioning or Separation Problem	4	4
Defective Component	4	4
Defective Device	4	4
Stretched	4	4
Separation Problem	3	3
Premature Separation	3	3
Device Dislodged or Dislocated	3	3
Incomplete or Inadequate Connection	3	3
Failure to Infuse	3	3
Device Damaged Prior to Use	3	3
Fracture	3	3
Material Puncture/Hole	3	3
Material Rupture	3	3
Unraveled Material	3	3
Dull, Blunt	2	2
Material Deformation	2	2
Gas/Air Leak	2	2
Contamination	2	2
Unintended Movement	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
Material Too Rigid or Stiff	1	1
Use of Device Problem	1	1
Positioning Failure	1	1
Contamination /Decontamination Problem	1	1
Failure to Deliver	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	389	390
Foreign Body In Patient	103	105
Insufficient Information	59	62
Pain	16	16
Needle Stick/Puncture	15	15
Unspecified Infection	6	6
Device Embedded In Tissue or Plaque	6	6
Discomfort	6	6
Headache	4	4
Inadequate Pain Relief	3	3
Perforation	3	3
Bacterial Infection	3	3
Swelling/ Edema	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Hematoma	2	2
Embolism/Embolus	2	2
Hemorrhage/Bleeding	2	2
Cerebrospinal Fluid Leakage	2	2
Spinal Column Injury	2	2
Paresthesia	2	2
Distress	1	1
Pulmonary Embolism	1	1
Low Oxygen Saturation	1	1
Eye Pain	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