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	190	193
Fluid/Blood Leak	71	71
Material Twisted/Bent	68	68
Material Separation	66	66
Obstruction of Flow	56	56
No Flow	41	41
Difficult to Advance	41	41
Failure to Advance	23	23
Physical Resistance/Sticking	22	22
Detachment of Device or Device Component	21	22
Material Fragmentation	17	19
Adverse Event Without Identified Device or Use Problem	16	16
Leak/Splash	15	15
Difficult to Remove	15	17
Material Too Soft/Flexible	14	14
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	7	7
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
Crack	3	3
Device Damaged Prior to Use	3	3
Device Dislodged or Dislocated	3	3
Incomplete or Inadequate Connection	3	3
Failure to Infuse	3	3
Premature Separation	3	3
Material Deformation	3	3
Material Rupture	3	3
Separation Problem	3	3
Unraveled Material	3	3
Flushing Problem	2	2
Connection Problem	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	422	423
Foreign Body In Patient	115	117
No Consequences Or Impact To Patient	85	85
Insufficient Information	61	64
No Patient Involvement	28	28
Pain	23	23
Device Embedded In Tissue or Plaque	17	17
Needle Stick/Puncture	15	15
Discomfort	7	7
Unspecified Infection	6	6
No Information	6	6
No Known Impact Or Consequence To Patient	5	5
Headache	4	4
Perforation	3	3
Bacterial Infection	3	3
Inadequate Pain Relief	3	3
Swelling/ Edema	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Paresthesia	2	2
Embolism/Embolus	2	2
Spinal Column Injury	2	2
Cerebrospinal Fluid Leakage	2	2
Hematoma	2	2
Hemorrhage/Bleeding	2	2
Hypersensitivity/Allergic reaction	1	1
Pneumothorax	1	1
Sepsis	1	1
Purulent Discharge	1	1
Dyspnea	1	1
Fever	1	1
Foreign Body Reaction	1	1
Cellulitis	1	1
Pulmonary Embolism	1	1
Abscess	1	1
Awareness during Anaesthesia	1	1
Tachycardia	1	1
Perforation of Vessels	1	1
Vomiting	1	1
Muscle Weakness	1	1
Neuropathy	1	1
Rupture	1	1
Distress	1	1
Fungal Infection	1	1
Low Oxygen Saturation	1	1
Decreased Sensitivity	1	1
Patient Problem/Medical Problem	1	1
Respiratory Insufficiency	1	1
Eye Pain	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Unspecified Tissue Injury	1	1