TPLC - Total Product Life Cycle

show TPLC since

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	187	190
Fluid/Blood Leak	68	68
Material Separation	65	65
Material Twisted/Bent	58	58
Obstruction of Flow	56	56
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	21
Material Fragmentation	16	18
Adverse Event Without Identified Device or Use Problem	16	16
Leak/Splash	15	15
Difficult to Remove	14	16
Material Split, Cut or Torn	12	12
Disconnection	11	11
Fracture	10	10
Unsealed Device Packaging	9	9
Material Integrity Problem	8	8
Stretched	8	8
Complete Blockage	6	6
Material Too Soft/Flexible	6	6
Burst Container or Vessel	5	5
Shipping Damage or Problem	5	5
Material Puncture/Hole	4	4
Defective Component	4	4
Defective Device	4	4
Activation, Positioning or Separation Problem	4	4
Incomplete or Inadequate Connection	3	3
Crack	3	3
Device Damaged Prior to Use	3	3
Device Dislodged or Dislocated	3	3
Failure to Infuse	3	3
Premature Separation	3	3
Material Rupture	3	3
Separation Problem	3	3
Unraveled Material	3	3
Flushing Problem	2	2
Connection Problem	2	2
Material Deformation	2	2
Dull, Blunt	2	2
Gas/Air Leak	2	2
Contamination	2	2
Unintended Movement	2	2
Difficult to Flush	2	2
Device Markings/Labelling Problem	2	2
Malposition of Device	2	2
Device Contamination with Body Fluid	2	2
Mechanical Problem	2	2
Entrapment of Device	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	402	403
Foreign Body In Patient	111	113
No Consequences Or Impact To Patient	85	85
Insufficient Information	60	63
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
Perforation	3	3
Hemorrhage/Bleeding	2	2
Cerebrospinal Fluid Leakage	2	2
Paresthesia	2	2
Spinal Column Injury	2	2
Embolism/Embolus	2	2
Hematoma	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Foreign Body Reaction	1	1
Cellulitis	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Fever	1	1
Rupture	1	1
Purulent Discharge	1	1
Vomiting	1	1
Muscle Weakness	1	1
Awareness during Anaesthesia	1	1
Dyspnea	1	1
No Code Available	1	1
Abscess	1	1
Tachycardia	1	1
Perforation of Vessels	1	1
Unspecified Tissue Injury	1	1
Fungal Infection	1	1
Sepsis	1	1
Convulsion/Seizure	1	1
Decreased Sensitivity	1	1
Pneumothorax	1	1
Hypersensitivity/Allergic reaction	1	1
Patient Problem/Medical Problem	1	1
Respiratory Insufficiency	1	1
Eye Pain	1	1
Low Oxygen Saturation	1	1
Pulmonary Embolism	1	1