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
1. K231242 Perifix FX Catheter; Contiplex FX Catheter
EPIMED INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
HK SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
JMT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	190	193
Material Twisted/Bent	84	84
Fluid/Blood Leak	73	73
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	22	23
Material Fragmentation	17	19
Material Too Soft/Flexible	16	16
Adverse Event Without Identified Device or Use Problem	16	16
Leak/Splash	15	15
Difficult to Remove	15	17
Material Split, Cut or Torn	12	12
Disconnection	11	11
Fracture	10	10
Unsealed Device Packaging	9	9
Stretched	8	8
Material Integrity Problem	8	8
Complete Blockage	7	7
Shipping Damage or Problem	5	5
Burst Container or Vessel	5	5
Material Puncture/Hole	4	4
Defective Component	4	4
Defective Device	4	4
Activation, Positioning or Separation Problem	4	4
Failure to Infuse	3	3
Device Dislodged or Dislocated	3	3
Device Damaged Prior to Use	3	3
Crack	3	3
Incomplete or Inadequate Connection	3	3
Material Deformation	3	3
Material Rupture	3	3
Premature Separation	3	3
Separation Problem	3	3
Unraveled Material	3	3
Flushing Problem	2	2
Connection Problem	2	2
Gas/Air Leak	2	2
Dull, Blunt	2	2
Component Missing	2	2
Use of Device Problem	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

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	433	434
Foreign Body In Patient	115	117
No Consequences Or Impact To Patient	85	85
Insufficient Information	67	70
No Patient Involvement	28	28
Pain	23	23
Device Embedded In Tissue or Plaque	17	17
Needle Stick/Puncture	15	15
Discomfort	8	8
Unspecified Infection	6	6
No Information	6	6
No Known Impact Or Consequence To Patient	5	5
Inadequate Pain Relief	4	4
Headache	4	4
Bacterial Infection	3	3
Cerebrospinal Fluid Leakage	3	3
Swelling/ Edema	3	3
Perforation	3	3
Hemorrhage/Bleeding	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