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	166	166
Fluid/Blood Leak	56	56
Obstruction of Flow	52	52
Material Separation	50	50
No Flow	41	41
Difficult to Advance	41	41
Material Twisted/Bent	31	31
Failure to Advance	23	23
Physical Resistance/Sticking	21	21
Detachment of Device or Device Component	19	19
Adverse Event Without Identified Device or Use Problem	16	16
Material Fragmentation	16	16
Difficult to Remove	14	14
Leak/Splash	13	13
Disconnection	11	11
Material Split, Cut or Torn	10	10
Fracture	10	10
Unsealed Device Packaging	9	9
Material Integrity Problem	8	8
Stretched	7	7
Shipping Damage or Problem	5	5
Burst Container or Vessel	5	5
Complete Blockage	5	5
Material Puncture/Hole	4	4
Activation, Positioning or Separation Problem	4	4
Material Rupture	3	3
Unraveled Material	3	3
Device Damaged Prior to Use	3	3
Material Too Soft/Flexible	3	3
Defective Device	3	3
Device Dislodged or Dislocated	3	3
Premature Separation	3	3
Unintended Movement	2	2
Flushing Problem	2	2
Entrapment of Device	2	2
Separation Problem	2	2
Crack	2	2
Contamination	2	2
Gas/Air Leak	2	2
Device Markings/Labelling Problem	2	2
Mechanical Problem	2	2
Dull, Blunt	2	2
Device Contamination with Body Fluid	2	2
Defective Component	2	2
Difficult to Insert	1	1
Loose or Intermittent Connection	1	1
Incomplete or Inadequate Connection	1	1
Nonstandard Device	1	1
Sharp Edges	1	1
Delivered as Unsterile Product	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	345	345
Foreign Body In Patient	92	92
No Consequences Or Impact To Patient	85	85
Insufficient Information	50	50
No Patient Involvement	28	28
Device Embedded In Tissue or Plaque	16	16
Pain	15	15
Needle Stick/Puncture	12	12
No Information	6	6
Unspecified Infection	6	6
No Known Impact Or Consequence To Patient	5	5
Discomfort	4	4
Headache	4	4
Swelling/ Edema	3	3
Inadequate Pain Relief	3	3
Bacterial Infection	3	3
Embolism/Embolus	2	2
Paresthesia	2	2
Spinal Column Injury	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Hemorrhage/Bleeding	2	2
Hematoma	2	2
Cerebrospinal Fluid Leakage	2	2
Respiratory Insufficiency	1	1
Convulsion/Seizure	1	1
No Code Available	1	1
Patient Problem/Medical Problem	1	1
Decreased Sensitivity	1	1
Hypersensitivity/Allergic reaction	1	1
Fever	1	1
Dyspnea	1	1
Purulent Discharge	1	1
Cellulitis	1	1
Awareness during Anaesthesia	1	1
Abscess	1	1
Pulmonary Embolism	1	1
Low Oxygen Saturation	1	1
Fungal Infection	1	1
Distress	1	1
Unspecified Tissue Injury	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Rupture	1	1
Vomiting	1	1
Perforation of Vessels	1	1
Tachycardia	1	1
Sepsis	1	1
Perforation	1	1
Neuropathy	1	1
Muscle Weakness	1	1