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
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
1. K230603 Arrow Non-Stimulating SnapLock Adapter (K-05520-00 ...

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	765	765
Obstruction of Flow	85	85
Fluid/Blood Leak	73	73
Difficult to Advance	68	68
Detachment of Device or Device Component	66	66
Material Separation	58	58
Material Twisted/Bent	53	53
No Flow	47	47
Failure to Advance	27	27
Physical Resistance/Sticking	24	24
Adverse Event Without Identified Device or Use Problem	19	19
Difficult to Remove	19	19
Material Fragmentation	18	18
Material Split, Cut or Torn	17	17
Leak/Splash	14	14
Disconnection	12	12
Crack	10	10
Fracture	10	10
Unsealed Device Packaging	10	10
Material Integrity Problem	8	8
Stretched	8	8
Activation, Positioning or Separation Problem	7	7
Defective Device	6	6
Burst Container or Vessel	5	5
Loose or Intermittent Connection	5	5
Complete Blockage	5	5
Material Rupture	5	5
Shipping Damage or Problem	5	5
Material Puncture/Hole	4	4
Packaging Problem	4	4
Component Missing	4	4
Premature Separation	3	3
Material Too Soft/Flexible	3	3
Device Dislodged or Dislocated	3	3
Product Quality Problem	3	3
Unraveled Material	3	3
Entrapment of Device	3	3
Defective Component	3	3
Device Damaged Prior to Use	3	3
Dull, Blunt	2	2
Separation Problem	2	2
Mechanical Jam	2	2
Contamination	2	2
Gas/Air Leak	2	2
Mechanical Problem	2	2
Connection Problem	2	2
Flushing Problem	2	2
Unintended Movement	2	2
Material Deformation	2	2
Device Contamination with Body Fluid	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	526	526
No Clinical Signs, Symptoms or Conditions	350	350
No Consequences Or Impact To Patient	233	233
Foreign Body In Patient	107	107
No Information	62	62
Insufficient Information	50	50
Not Applicable	33	33
Device Embedded In Tissue or Plaque	25	25
No Known Impact Or Consequence To Patient	23	23
Pain	20	20
Needle Stick/Puncture	12	12
Unspecified Infection	7	7
Discomfort	6	6
Headache	4	4
No Code Available	3	3
Inadequate Pain Relief	3	3
Bacterial Infection	3	3
Hemorrhage/Bleeding	3	3
Swelling/ Edema	3	3
Patient Problem/Medical Problem	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Embolism/Embolus	2	2
Hematoma	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
Perforation of Vessels	1	1
Unspecified Tissue Injury	1	1
Tachycardia	1	1
Abscess	1	1
Sedation	1	1
Awareness during Anaesthesia	1	1
Dyspnea	1	1
Vomiting	1	1
Fever	1	1
Burn(s)	1	1
Foreign Body Reaction	1	1
Cellulitis	1	1
Rupture	1	1
Purulent Discharge	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Perforation	1	1
Muscle Weakness	1	1
Fungal Infection	1	1
Sepsis	1	1