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	160	160
Fluid/Blood Leak	54	54
Obstruction of Flow	52	52
Material Separation	47	47
No Flow	41	41
Difficult to Advance	41	41
Material Twisted/Bent	31	31
Failure to Advance	23	23
Physical Resistance/Sticking	20	20
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	7	7
Stretched	7	7
Burst Container or Vessel	5	5
Complete Blockage	5	5
Shipping Damage or Problem	5	5
Activation, Positioning or Separation Problem	4	4
Premature Separation	3	3
Material Too Soft/Flexible	3	3
Device Damaged Prior to Use	3	3
Material Puncture/Hole	3	3
Material Rupture	3	3
Defective Device	3	3
Unraveled Material	3	3
Dull, Blunt	2	2
Flushing Problem	2	2
Device Dislodged or Dislocated	2	2
Gas/Air Leak	2	2
Contamination	2	2
Defective Component	2	2
Unintended Movement	2	2
Device Markings/Labelling Problem	2	2
Crack	2	2
Device Contamination with Body Fluid	2	2
Mechanical Problem	2	2
Entrapment of Device	2	2
Separation Problem	2	2
Difficult to Insert	1	1
Contamination /Decontamination Problem	1	1
Failure to Deliver	1	1
Positioning Failure	1	1
Material Too Rigid or Stiff	1	1
Component Missing	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	340	340
Foreign Body In Patient	87	87
No Consequences Or Impact To Patient	85	85
Insufficient Information	48	48
No Patient Involvement	28	28
Device Embedded In Tissue or Plaque	16	16
Pain	14	14
Needle Stick/Puncture	12	12
Unspecified Infection	6	6
No Information	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
Discomfort	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
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
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
Neuropathy	1	1