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
EPIMED INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
HK SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
1. K193664 SubQKath Catheter and Needle Set
JMT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	173	173
Material Twisted/Bent	137	137
Fluid/Blood Leak	86	86
Material Separation	67	67
Obstruction of Flow	57	57
No Flow	41	41
Difficult to Advance	41	41
Failure to Advance	23	23
Material Too Soft/Flexible	18	18
Adverse Event Without Identified Device or Use Problem	18	18
Physical Resistance/Sticking	18	18
Detachment of Device or Device Component	17	18
Leak/Splash	15	15
Material Fragmentation	15	17
Disconnection	13	13
Material Split, Cut or Torn	13	13
Difficult to Remove	12	12
Fracture	9	9
Unsealed Device Packaging	9	9
Stretched	7	7
Material Integrity Problem	7	7
Complete Blockage	7	7
Material Puncture/Hole	5	5
Burst Container or Vessel	5	5
Device Damaged Prior to Receipt by User	5	5
Activation, Positioning or Separation Problem	4	4
Defective Component	4	4
Premature Separation	3	3
Device Dislodged or Dislocated	3	3
Separation Problem	3	3
Failure to Infuse	3	3
Crack	3	3
Incomplete or Inadequate Connection	3	3
Material Deformation	3	3
Material Rupture	3	3
Dull, Blunt	2	2
Pressure Problem	2	2
Nonstandard Device	2	2
Mechanical Problem	2	2
Device Contamination with Body Fluid	2	2
Gas/Air Leak	2	2
Malposition of Device	2	2
Use of Device Problem	2	2
Positioning Failure	2	2
Unraveled Material	2	2
Device Damaged Prior to Use	2	2
Device Markings/Labelling Problem	2	2
Defective Device	2	2
Unintended Movement	2	2
Difficult to Flush	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	497	498
Foreign Body In Patient	118	120
No Consequences Or Impact To Patient	85	85
Insufficient Information	78	81
No Patient Involvement	28	28
Pain	26	26
Device Embedded In Tissue or Plaque	17	17
Needle Stick/Puncture	15	15
Discomfort	8	8
Cerebrospinal Fluid Leakage	6	6
No Information	6	6
Unspecified Infection	6	6
Headache	5	5
No Known Impact Or Consequence To Patient	5	5
Inadequate Pain Relief	4	4
Hematoma	3	3
Perforation	3	3
Bacterial Infection	3	3
Swelling/ Edema	3	3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Eye Pain	2	2
Hemorrhage/Blood Loss/Bleeding	2	2
Paresthesia	2	2
Spinal Column Injury	2	2
Medical device site infection	2	2
Purulent Discharge	2	2
Embolism/Embolus	2	2
Inflammation	2	2
Cellulitis	1	1
Foreign Body Reaction	1	1
No Code Available	1	1
Fungal Infection	1	1
Fever	1	1
Sepsis	1	1
Pneumothorax	1	1
Hypersensitivity/Allergic reaction	1	1
Vomiting	1	1
Hyporesponsive to stimuli	1	1
Patient Problem/Medical Problem	1	1
Awareness during Anaesthesia	1	1
Dyspnea	1	1
Abscess	1	1
Tachycardia	1	1
Perforation of Vessels	1	1
Unspecified Tissue Injury	1	1
Neuropathy	1	1
Convulsion/Seizure	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Muscle Weakness/Atrophy	1	1
Rupture	1	1