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

Premarket Reviews
Manufacturer	Decision
B. BRAUN MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
CIMPAX APS
	SUBSTANTIALLY EQUIVALENT	1
1. K191470 C-CAT Anaesthesia Catheter kit
EPIMED INTERNATIONAL INC.
	SUBSTANTIALLY EQUIVALENT	1
HK SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
JMT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	776	779
Obstruction of Flow	89	89
Fluid/Blood Leak	82	82
Material Twisted/Bent	70	70
Difficult to Advance	68	68
Detachment of Device or Device Component	67	67
Material Separation	63	63
No Flow	47	47
Failure to Advance	27	27
Physical Resistance/Sticking	24	24
Material Split, Cut or Torn	19	19
Adverse Event Without Identified Device or Use Problem	19	19
Difficult to Remove	19	21
Material Fragmentation	18	18
Leak/Splash	15	15
Disconnection	12	12
Crack	10	10
Fracture	10	10
Unsealed Device Packaging	10	10
Stretched	9	9
Material Integrity Problem	8	8
Activation, Positioning or Separation Problem	7	7
Defective Device	6	6
Complete Blockage	6	6
Loose or Intermittent Connection	5	5
Shipping Damage or Problem	5	5
Material Rupture	5	5
Burst Container or Vessel	5	5
Material Puncture/Hole	4	4
Material Too Soft/Flexible	4	4
Packaging Problem	4	4
Component Missing	4	4
Device Dislodged or Dislocated	3	3
Defective Component	3	3
Failure to Infuse	3	3
Device Damaged Prior to Use	3	3
Premature Separation	3	3
Incomplete or Inadequate Connection	3	3
Product Quality Problem	3	3
Material Deformation	3	3
Entrapment of Device	3	3
Unraveled Material	3	3
Separation Problem	3	3
Flushing Problem	2	2
Connection Problem	2	2
Mechanical Jam	2	2
Dull, Blunt	2	2
Gas/Air Leak	2	2
Contamination	2	2
Unintended Movement	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	526	526
No Clinical Signs, Symptoms or Conditions	384	384
No Consequences Or Impact To Patient	233	233
Foreign Body In Patient	117	117
No Information	62	62
Insufficient Information	58	61
Not Applicable	33	33
Device Embedded In Tissue or Plaque	25	25
Pain	24	24
No Known Impact Or Consequence To Patient	23	23
Needle Stick/Puncture	15	15
Unspecified Infection	7	7
Discomfort	6	6
Headache	4	4
Inadequate Pain Relief	3	3
Hemorrhage/Bleeding	3	3
Bacterial Infection	3	3
No Code Available	3	3
Swelling/ Edema	3	3
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
Patient Problem/Medical Problem	2	2
Foreign Body Reaction	1	1
Cellulitis	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Rupture	1	1
Burn(s)	1	1
Fever	1	1
Purulent Discharge	1	1
Vomiting	1	1
Perforation	1	1
Muscle Weakness	1	1
Awareness during Anaesthesia	1	1
Dyspnea	1	1
Abscess	1	1
Sedation	1	1
Tachycardia	1	1
Perforation of Vessels	1	1
Unspecified Tissue Injury	1	1
Fungal Infection	1	1
Convulsion/Seizure	1	1
Sepsis	1	1
Decreased Sensitivity	1	1
Hypersensitivity/Allergic reaction	1	1
Respiratory Insufficiency	1	1
Eye Pain	1	1