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
JMT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
1. K230603 Arrow Non-Stimulating SnapLock Adapter (K-05520-00 ...

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Twisted/Bent	121	121
Break	113	113
Fluid/Blood Leak	77	77
Material Separation	63	63
Obstruction of Flow	47	47
No Flow	37	37
Difficult to Advance	20	20
Adverse Event Without Identified Device or Use Problem	18	18
Material Too Soft/Flexible	18	18
Physical Resistance/Sticking	17	17
Material Fragmentation	15	17
Disconnection	13	13
Leak/Splash	12	12
Difficult to Remove	11	11
Material Split, Cut or Torn	11	11
Detachment of Device or Device Component	10	11
Unsealed Device Packaging	9	9
Material Integrity Problem	7	7
Complete Blockage	7	7
Failure to Advance	7	7
Burst Container or Vessel	5	5
Material Puncture/Hole	4	4
Defective Component	4	4
Activation, Positioning or Separation Problem	4	4
Premature Separation	3	3
Fracture	3	3
Incomplete or Inadequate Connection	3	3
Device Dislodged or Dislocated	3	3
Separation Problem	3	3
Failure to Infuse	3	3
Material Rupture	3	3
Material Deformation	3	3
Stretched	3	3
Device Contamination with Body Fluid	2	2
Unintended Movement	2	2
Unraveled Material	2	2
Device Damaged Prior to Use	2	2
Gas/Air Leak	2	2
Pressure Problem	2	2
Use of Device Problem	2	2
Nonstandard Device	2	2
Malposition of Device	2	2
Mechanical Problem	2	2
Dull, Blunt	2	2
Defective Device	2	2
Device Markings/Labelling Problem	2	2
Tear, Rip or Hole in Device Packaging	1	1
Component or Accessory Incompatibility	1	1
Contamination /Decontamination Problem	1	1
Crack	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	467	468
Foreign Body In Patient	109	111
Insufficient Information	74	77
Pain	21	21
Needle Stick/Puncture	15	15
Discomfort	8	8
Device Embedded In Tissue or Plaque	7	7
Unspecified Infection	6	6
Headache	5	5
Inadequate Pain Relief	4	4
Perforation	3	3
Hematoma	3	3
Cerebrospinal Fluid Leakage	3	3
Swelling/ Edema	3	3
Bacterial Infection	3	3
Eye Pain	2	2
Purulent Discharge	2	2
Embolism/Embolus	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Spinal Column Injury	2	2
Medical device site infection	2	2
Inflammation	2	2
Hemorrhage/Blood Loss/Bleeding	2	2
Paresthesia	2	2
Hyporesponsive to stimuli	1	1
Unspecified Tissue Injury	1	1
Hypersensitivity/Allergic reaction	1	1
Tachycardia	1	1
Paraplegia	1	1
Convulsion/Seizure	1	1
Respiratory Insufficiency	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Rupture	1	1
Cellulitis	1	1
Dyspnea	1	1
Muscle Weakness/Atrophy	1	1
Distress	1	1
Pulmonary Embolism	1	1
Low Oxygen Saturation	1	1
Sepsis	1	1
Abscess	1	1
Foreign Body Reaction	1	1
Awareness during Anaesthesia	1	1
Perforation of Vessels	1	1
Pneumothorax	1	1
Neuropathy	1	1
Fever	1	1
Fungal Infection	1	1