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	178	181
Fluid/Blood Leak	66	66
Material Separation	62	62
Obstruction of Flow	56	56
Material Twisted/Bent	48	48
No Flow	41	41
Difficult to Advance	41	41
Failure to Advance	23	23
Physical Resistance/Sticking	21	21
Detachment of Device or Device Component	20	20
Adverse Event Without Identified Device or Use Problem	16	16
Material Fragmentation	16	16
Leak/Splash	14	14
Difficult to Remove	14	16
Material Split, Cut or Torn	12	12
Disconnection	11	11
Fracture	10	10
Unsealed Device Packaging	9	9
Stretched	8	8
Material Integrity Problem	8	8
Complete Blockage	6	6
Burst Container or Vessel	5	5
Shipping Damage or Problem	5	5
Activation, Positioning or Separation Problem	4	4
Material Too Soft/Flexible	4	4
Material Puncture/Hole	4	4
Defective Device	4	4
Premature Separation	3	3
Device Dislodged or Dislocated	3	3
Failure to Infuse	3	3
Material Rupture	3	3
Unraveled Material	3	3
Defective Component	3	3
Separation Problem	3	3
Device Damaged Prior to Use	3	3
Incomplete or Inadequate Connection	3	3
Dull, Blunt	2	2
Contamination	2	2
Unintended Movement	2	2
Gas/Air Leak	2	2
Entrapment of Device	2	2
Difficult to Flush	2	2
Flushing Problem	2	2
Device Markings/Labelling Problem	2	2
Material Deformation	2	2
Mechanical Problem	2	2
Crack	2	2
Device Contamination with Body Fluid	2	2
Component or Accessory Incompatibility	1	1
Pressure Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	384	384
Foreign Body In Patient	106	106
No Consequences Or Impact To Patient	85	85
Insufficient Information	58	61
No Patient Involvement	28	28
Pain	21	21
Device Embedded In Tissue or Plaque	16	16
Needle Stick/Puncture	15	15
Unspecified Infection	6	6
No Information	6	6
Discomfort	6	6
No Known Impact Or Consequence To Patient	5	5
Headache	4	4
Inadequate Pain Relief	3	3
Bacterial Infection	3	3
Swelling/ Edema	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Hematoma	2	2
Hemorrhage/Bleeding	2	2
Embolism/Embolus	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
Vomiting	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
Perforation	1	1
Muscle Weakness	1	1
No Code Available	1	1
Fungal Infection	1	1
Sepsis	1	1
Decreased Sensitivity	1	1
Hypersensitivity/Allergic reaction	1	1
Patient Problem/Medical Problem	1	1